Delivery devices for forming a distal anchor for mitral valve repair

ABSTRACT

Described herein are devices and methods for mitral valve repair. The devices and methods implant a plurality of distal anchors at an annulus of the mitral valve (e.g., the posterior annulus) and tension artificial chordae to pull the portion of the annulus toward an opposite edge and inward into the ventricle. This can effectively reduce the size of the orifice and increase coaptation. The delivery devices can be configured to be actuated to form a distal anchor made of a pre-formed knot. The delivery devices deliver the pre-formed knot in an elongate configuration. Actuation of the delivery device causes the pre-formed knot to transition from the elongate configuration to the deployed configuration by approximating opposite ends of a suture coupled to a coiled configuration to form one or more loops. After formation of the knot, the delivery device can be withdrawn.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/950,458, filed Apr. 11, 2018, which is a continuation ofInternational Patent Application No. PCT/US18/26570, filed Apr. 6, 2018,which claims the benefit of U.S. Patent Application No. 62/482,468,filed Apr. 6, 2017, each of which is expressly incorporated by referenceherein in its entirety for all purposes.

BACKGROUND Field

Some embodiments described herein relate to methods and apparatus forperforming cardiac valve repairs, and more particularly, methods andapparatus for performing minimally invasive mitral or tricuspid valverepairs.

Description of Related Art

Various disease processes can impair the proper functioning of one ormore of the valves of the heart. These disease processes includedegenerative processes (e.g., Barlow's Disease, fibroelasticdeficiency), inflammatory processes (e.g., Rheumatic Heart Disease), andinfectious processes (e.g., endocarditis). Additionally, damage to theventricle from prior heart attacks (e.g., myocardial infarctionsecondary to coronary artery disease) or other heart diseases (e.g.,cardiomyopathy) can distort the geometry of the heart causing valves inthe heart to dysfunction. The vast majority of patients undergoing valvesurgery, such as mitral valve surgery, suffer from a degenerativedisease that causes a malfunction in a leaflet of the valve, whichresults in prolapse and regurgitation.

Generally, a heart valve may malfunction in two different ways. Onepossible malfunction, valve stenosis, occurs when a valve does not opencompletely and thereby causes an obstruction of blood flow. Typically,stenosis results from buildup of calcified material on the leaflets ofthe valves causing them to thicken and thereby impairing their abilityto fully open and permit adequate forward blood flow.

Another possible malfunction, valve regurgitation, occurs when theleaflets of the valve do not close completely thereby causing blood toleak back into the prior chamber. There are three mechanisms by which avalve becomes regurgitant or incompetent; they include Carpentier's typeI, type II and type III malfunctions. A Carpentier type I malfunctioninvolves the dilation of the annulus such that the area of the valveorifice increases. The otherwise normally functioning leaflets do nothave enough surface area to cover the enlarged orifice and fail to forma tight seal (e.g., do not coapt properly) causing regurgitation.Included in a type I mechanism malfunction are perforations of the valveleaflets, as in endocarditis. A Carpentier's type II malfunctioninvolves prolapse of a segment of one or both leaflets above the planeof the annulus. This is the most commonly treated cause of mitralregurgitation, and is often caused by the stretching or rupturing ofchordae tendineae normally connected to the leaflet. A Carpentier's typeIII malfunction involves restriction of the motion of one or moreleaflets such that the leaflets are abnormally constrained below thelevel of the plane of the annulus. Leaflet restriction can be caused byrheumatic disease (Ma) or dilation of the ventricle (Mb).

Mitral valve disease is the most common valvular heart disorder, withnearly 4 million Americans estimated to have moderate to severe mitralvalve regurgitation (“MR”). MR results in a volume overload on the leftventricle which in turn progresses to ventricular dilation, decreasedejection performance, pulmonary hypertension, symptomatic congestiveheart failure, atrial fibrillation, right ventricular dysfunction andeventually death. Successful surgical mitral valve repair restoresmitral valve competence, abolishes the volume overload on the leftventricle, improves symptom status, prevents adverse left ventricularremodeling and dramatically improves life expectancy, often returning itto that of a normal member of the population.

Malfunctioning valves may either be repaired or replaced. Repairtypically involves the preservation and correction of the patient's ownvalve. Replacement typically involves replacing the patient'smalfunctioning valve with a biological or mechanical substitute.Typically, replacement is preferred for stenotic damage sustained by theleaflets because the stenosis is irreversible. The mitral valve andtricuspid valve, on the other hand, are more prone to deformation.Deformation of the leaflets, as described above, prevents the valvesfrom closing properly and allows for regurgitation or back flow of bloodfrom the ventricle into the atrium, which results in valvularinsufficiency. Deformations in the structure or shape of the mitralvalve or tricuspid valve are often repairable.

In mitral valve regurgitation, repair is preferable to valvereplacement. Mitral valve replacement operations have a 2× higher riskof operative mortality (Risk Standardized Mortality 1.65% vs 2.96%),2×higher risk of stroke per year (1.15%±0.1% vs 2.2%±0.4%) and a10×higher risk of infection per year (0.1% vs 1.0%). Patients whoreceive a quality mitral valve repair operation do not requireanticoagulation and rarely require reoperation. This is in starkcontrast to mechanical valve replacement which mandates lifelonganticoagulation and bioprosthetic valve replacement with the eventualcertainty of prosthetic valve dysfunction and reoperation. Compared tomitral valve replacement, mitral valve repair results in improved leftventricular function and has superior long-term survival. Therefore, animproperly functioning mitral valve or tricuspid valve is ideallyrepaired, rather than replaced. However, because of the complex andtechnical demands of the repair procedures, the mitral valve is stillreplaced in approximately one third of all mitral valve operationsperformed in the United States.

Studies suggest that Carpentier type II malfunction, often referred toas “Degenerative,” “Primary” or “Organic” MR, accounts for as much as60% of MR. Resectional mitral valve repair techniques, initiallydescribed by Dr. Carpentier, involve cutting out (resecting) a sectionof the prolapsed leaflet tissue, stitching the remaining tissue togetherand implanting an annuloplasty ring around the annulus. Removing aportion of one or both of the mitral valve leaflets during such aresectional repair decreases the available leaflet tissue to seal themitral orifice. To accommodate the decrease caused by the resectionalrepair, in many instances, an annuloplasty ring must be implanted todecrease the size of the mitral orifice.

Implanting an annuloplasty ring introduces various risks. For example,implanting an annuloplasty ring can increase pressure gradients acrossthe valve. Further, an annuloplasty ring can lead to infection and/orannuloplasty ring dehiscence: a well-documented failure mode of valverepair surgery. Implanting an annuloplasty ring can further impact thedynamic nature of the mitral valve annulus throughout the cardiac cycle.In a healthy person, for example, the mitral valve annulus relaxesduring diastole and contracts with the rest of the left ventricle duringsystole, causing the annulus to expand and contract as the heart beats.Implanting an annuloplasty ring can interfere with such normalfunctioning of the heart. To combat such interference, flexibleannuloplasty rings and partial bands have been developed to minimize theimpact a rigid or complete annuloplasty ring can have on the dynamicmovement of the mitral annulus. To avoid the aforementionedcomplications and risks, an effective mitral valve repair procedure thateliminated the need for an annuloplasty ring is desirable, particularlya repair that can be performed minimally-invasively and off-pump inwhich implanting an annuloplasty ring would be present technicalchallenges.

More recently many surgeons have moved to a “non-resectional” repairtechnique where artificial chordae tendineae (“cords”) made of ePTFEsuture, or another suitable material, are placed in the prolapsedleaflet and secured to the heart in the left ventricle, normally to thepapillary muscle. Because the native leaflet tissue is maintained innon-resectional repairs, they often result in a larger surface ofcoaptation between the posterior and anterior mitral valve leaflets, butproperly sizing the cords on a flaccid heart can be very challenging,especially for the low volume mitral valve surgeon. Implanting anannuloplasty ring with such non-resectional repairs on a stopped heartis currently the standard of care. Implanting an annuloplasty ring in abeating heart repair is technically challenging and rarely done inpractice due in large part to the costs associated with two separateprocedures (e.g., cordal repair and annuloplasty). A device that canquickly and easily perform a beating-heart cordal repair while alsoaddressing the mitral annulus would be a major advancement.

Carpentier type I malfunction, sometimes referred to as “Secondary” or“Functional” MR, is associated with heart failure and affects between1.6 and 2.8 million people in the United States alone. Studies haveshown that mortality doubles in patients with untreated mitral valveregurgitation after myocardial infarction. Unfortunately, there is nogold standard surgical treatment paradigm for functional MR and mostfunctional MR patients are not referred for surgical intervention due tothe significant morbidity, risk of complications and prolongeddisability associated with cardiac surgery. Surgeons use a variety ofapproaches ranging from valve replacement to insertion of an undersizedmitral valve annuloplasty ring for patients suffering from functional MRand the long-term efficacy is still unclear. In a randomized study ofon-pump, open-heart mitral valve repair versus mitral valve replacementfor functional MR, mitral valve replacement had a similar mortality rateand resulted in significantly less recurrent MR after one year and twoyears. According to some, a subsequent sub-analysis of subjects in therepair group suggests that the people who received a “good repair” didbetter than the replacement group but that when the repair arm wascompared to mitral valve replacement, the “bad repairs” caused thereplacement arm to perform better. Either way, there is a need forbetter treatment options for functional MR. Less invasive,beating-heart, transcatheter repair and replacement technologies are ofparticular interest because they do not require cardiopulmonary bypass,cardioplegia, aortic cross-clamping or median sternotomy.

Dr. Alfieri has demonstrated the benefit of securing the midpoint ofboth leaflets together creating a double orifice valve in patients withMR known as an “Edge-to-Edge” repair or an Alfieri procedure. Theability to combine a neochordal repair with an edge-to-edge repair indegenerative MR patients with a dilated annulus and who do not receivean annuloplasty ring because the repair is done in a minimally-invasive,off-pump procedure, has particular promise.

Regardless of whether a replacement or repair procedure is beingperformed, conventional approaches for replacing or repairing cardiacvalves are typically invasive open-heart surgical procedures, such assternotomy or thoracotomy, which require opening up of the thoraciccavity so as to gain access to the heart. Once the chest has beenopened, the heart is bypassed and stopped. Cardiopulmonary bypass istypically established by inserting cannulae into the superior andinferior vena cavae (for venous drainage) and the ascending aorta (forarterial perfusion), and connecting the cannulae to a heart-lungmachine, which functions to oxygenate the venous blood and pump it intothe arterial circulation, thereby bypassing the heart. Oncecardiopulmonary bypass has been achieved, cardiac standstill isestablished by clamping the aorta and delivering a “cardioplegia”solution into the aortic root and then into the coronary circulation,which stops the heart from beating. Once cardiac standstill has beenachieved, the surgical procedure may be performed. These procedures,however, adversely affect almost all of the organ systems of the bodyand may lead to complications, such as strokes, myocardial “stunning” ordamage, respiratory failure, kidney failure, bleeding, generalizedinflammation, and death. The risk of these complications is directlyrelated to the amount of time the heart is stopped (“cross-clamp time”)and the amount of time the subject is on the heart-lung machine (“pumptime”).

Thus, there is a significant need to perform mitral valve repairs usingless invasive procedures while the heart is still beating. Accordingly,there is a continuing need for new procedures and devices for performingcardiac valve repairs, such as mitral valve repair, which are lessinvasive, do not require cardiac arrest, and are less labor-intensiveand technically challenging.

SUMMARY

Apparatus and methods for performing a non-invasive procedure to repaira cardiac valve are described herein. In some embodiments, devices todeliver a distal anchor within the atrium of the heart are describedherein. Such a device can include a handle, an actuator operably coupledto the handle, a pusher device, a puncture member coupled to theactuator and at least partially disposed within a lumen defined by thepusher device, and a distal anchor. The distal anchor is disposed at adistal end portion of an artificial chordae and disposed in a deliveryconfiguration. The artificial chordae has a proximal end portion coupledto the actuator. The proximal end portion of the artificial chordaeextends through a lumen defined by the puncture member. The actuator canbe actuated to move the puncture member distally a preset distance, andto move the pusher device distally such that at least a portion of thedistal anchor is moved distal to the distal end of the puncture memberand the distal anchor is moved from its delivery configuration to adeployed configuration.

In a first aspect, the present disclosure provides a method forimplanting artificial chordae to improve coaptation. The method includesinserting a first artificial chordae having a first distal anchordisposed at a distal end portion of the first artificial chordae throughan apex region of a heart, through a ventricle of the heart, and to aproximal side of a posterior annulus of the mitral valve, the firstdistal anchor disposed in a delivery configuration. The method alsoincludes puncturing the posterior annulus to define an opening in theposterior annulus, the first artificial chordae extending through theopening so that the first distal anchor is positioned on a distal sideof the posterior annulus. The method also includes deploying the firstdistal anchor so that the first distal anchor is moved to a deployedconfiguration to secure the first artificial chordae to the posteriorannulus. The method also includes anchoring a proximal end portion ofthe first artificial chordae to the heart to apply a force on theposterior annulus, the force being directed anteriorly towards theanterior annulus and downward toward the ventricle.

In some embodiments of the first aspect, the method further includesimplanting a second artificial chordae in the posterior annulus, thesecond artificial chordae having a second distal anchor at a distal endportion. In further embodiments of the first aspect, the second distalanchor of the second artificial chordae is deployed less than about 7 mmfrom the first distal anchor on the posterior annulus. In furtherembodiments of the first aspect, the method further includes implantingless than or equal to four artificial chordae, each artificial chordaehaving a distal anchor at a respective distal end portion. In furtherembodiments of the first aspect, each of the distal anchors of therespective implanted artificial chordae are positioned at least about 3mm and less than or equal to about 7 mm from a nearest distal anchor onthe posterior annulus.

In some embodiments of the first aspect, the first artificial chordae isinserted at least about 1 cm lateral to the left coronary artery. Infurther embodiments of the first aspect, the first artificial chordae isinserted at least about 2 cm basal from a true apex of the heart.

In some embodiments of the first aspect, the method further includesinserting a second artificial chordae having a second distal anchordisposed at a distal end portion of the second artificial chordaethrough the apex region of the heart, through the ventricle of theheart, and to a proximal side of a posterior leaflet of the mitralvalve, the second distal anchor disposed in a delivery configuration;puncturing the posterior leaflet to define an opening in the posteriorleaflet, the second artificial chordae extending through the opening sothat the second distal anchor is positioned on a distal side of theposterior leaflet; deploying the second distal anchor so that it ismoved to a deployed configuration to secure the second artificialchordae to the posterior leaflet; and anchoring a proximal end portionof the second artificial chordae to the heart to apply a force on theposterior leaflet, the force being directed anteriorly towards theanterior leaflet and downward toward the ventricle. In furtherembodiments of the first aspect, the proximal end portion of the secondartificial chordae is anchored to the heart in a different location fromthe proximal end portion of the first artificial chordae. In furtherembodiments of the first aspect, the method further includes applying afirst tension to the first artificial chordae and a second tensiondifferent from the first tension to the second artificial chordae. Infurther embodiments of the first aspect, the first tension is greaterthan the second tension. In further embodiments of the first aspect, afirst delivery device is used to implant the first artificial chordaeand a second delivery device different from the first delivery device isused to implant the second artificial chordae.

In a second aspect, the present disclosure provides a method thatincludes inserting a first artificial chordae through an apex region ofa heart, through a ventricle of the heart, and to a proximal side of aposterior annulus of the mitral valve, the first artificial chordaehaving a first distal anchor disposed in a delivery configuration. Themethod also includes deploying the first distal anchor so that the firstdistal anchor is moved to a deployed configuration to secure the firstartificial chordae to the posterior annulus. The method also includesanchoring a proximal end portion of the first artificial chordae whereina first tension on the first artificial chordae is directed anteriorlytowards the anterior annulus and downward toward the ventricle. Themethod also includes inserting a second artificial chordae through theapex region of the heart, through the ventricle of the heart, and to aproximal side of a posterior leaflet of the mitral valve, the secondartificial chordae having a second distal anchor disposed in a deliveryconfiguration. The method also includes deploying the second distalanchor so that the second distal anchor is moved to a deployedconfiguration to secure the second artificial chordae to the posteriorleaflet. The method also includes anchoring a proximal end portion ofthe second artificial chordae wherein a second tension on the secondartificial chordae causes the posterior leaflet to move downward towardthe ventricle to increase coaptation.

In some embodiments of the second aspect, the first tension is greaterthan the second tension. In some embodiments of the second aspect, themethod further includes adjusting the first tension after anchoring ofthe second artificial chordae. In further embodiments of the secondaspect, the method further includes adjusting the second tensionindependent of adjustments to the first tension.

In some embodiments of the second aspect, the second tension isconfigured to cause the surface of coaptation to be at least about 4 mm.In some embodiments of the second aspect, the combination of the firsttension and the second tension decreases a distance between the anteriorannulus and the posterior annulus by at least about 10%. In someembodiments of the second aspect, the first artificial chordae isanchored to the heart in a different location from the second artificialchordae. In some embodiments of the second aspect, the second tension isconfigured to cause the second distal anchor to be below the anteriorleaflet during coaptation.

In a third aspect, the present disclosure provides for an apparatus thatincludes a pusher having a distal end. The apparatus also includes aneedle having a distal portion, the needle slidably disposed within thepusher with the distal portion of the needle extending from the distalend of the pusher. The apparatus also includes a suture having a firstsection and a second section, each of the first section and the secondsection having a first portion and a second portion, the second portionof each section including a coil that has a proximal end and a distalend and being formed of multiple turns about an exterior of the needle.A first end of the second portion of the first section is at the distalend of the coil of the first section. A first end of the second portionof the second section is coupled to the first end of the second portionof the first section. The first section forms a first loop formingsegment having a first end at the proximal end of the first coil, asecond end at the distal end of the first coil, and is routed proximallyexternal to the second coil and distally internal to the second coil.The second section forms a second loop forming segment having a firstend at the distal end of the second coil, a second end at the proximalend of the first coil, and is routed distally external to the first coiland proximally internal to the first coil. The second section forms afirst loop by routing the first portion of the second section proximallyalong the exterior of the coil of the second section and distallythrough the proximal end of the coil of the second section, internal tothe coil of the second section, and out a portion of the coil of thesecond section between the distal end and the proximal end of the coilof the second section. The first section forms a second loop by routingthe first portion of the first section distally along the exterior ofthe coil of the second section and proximally through the distal end ofthe coil of the first section, internal to the coil of the firstsection, and out a portion of the coil of the first section between thedistal end and the proximal end of the coil of the first section. Thefirst portion of the first section is crossed with the first portion ofthe second section and routed through the first loop. The first portionof the second section is crossed with the first portion of the firstsection and routed through the second loop.

In some embodiments of the third aspect, the suture is configured forthe coil of the first section and the coil of the second section to beformed into a flattened loop by withdrawing the needle proximallythrough the coil of the first section and the coil of the second sectionsuch that the pusher separates the coil of the first section and thecoil of the second section from the needle. In further embodiments ofthe third aspect, the apparatus is further configured to form theflattened loop by withdrawing the first portion of the second sectionrelative to the distal end of the pusher to draw the second end of thesecond loop forming segment proximally from the proximal end of the coilof the first section to deflect the distal end of the coil of the firstsection laterally with respect to the proximal end of the coil of thefirst section and to draw the proximal end and the distal end of thecoil of the first section towards each other to form a portion of theflattened loop. In further embodiments of the third aspect, theapparatus is further configured to form the flattened loop bywithdrawing the first portion of the first section relative to thedistal end of the pusher to draw the second end of the first loopforming segment proximally from the proximal end of the coil of thesecond section to deflect the distal end of the coil of the secondsection laterally with respect to the proximal end of the coil of thesecond section and to draw the proximal end and the distal end of thecoil of the second section towards each other to form a portion of theflattened loop.

In some embodiments of the third aspect, the needle defines an interiorlumen and a distal portion of the needle includes a slot incommunication with the lumen.

In a fourth aspect, the present disclosure provides for a method formanufacturing a suture with a distal anchor and a distal anchor made bythe method. The method includes forming a first coil on a distal portionof the needle, the first coil being formed of multiple turns of a secondportion of a first section of the suture about an exterior of theneedle, the first coil having a proximal end and a distal end. Themethod also includes forming a second coil on a proximal portion of theneedle, the second coil being formed of multiple turns of a secondportion of a second section the suture about an exterior of the needle,the second coil having a proximal end and a distal end. The method alsoincludes forming a first loop forming segment of the second portion ofthe first section by routing proximally the second portion of the firstsection from the proximal end of the first coil, external to the firstcoil and the second coil, towards the proximal end of the second coiland extending distally through the interior of the second coil to thedistal end of the second coil. The method also includes forming a secondloop forming segment of the second portion of the second section byrouting distally the second portion of the second section from thedistal end of the second coil, external to the first coil and the secondcoil, towards the distal end of the first coil and extending proximallythrough the interior of the first coil to the proximal end of the firstcoil. The method also includes forming a first loop by routing a firstportion of the second section proximally along the exterior of thesecond coil and then distally and internally through the proximal end ofthe second coil and out a portion of the second coil between the distalend and the proximal end of the second coil. The method also includesforming a second loop by routing a first portion of the first sectiondistally along the exterior of the first coil and then proximally andinternally through the distal end of the first coil and out a portion ofthe first coil between the distal end and the proximal end of the firstcoil. The method also includes crossing the first portion of the firstsection with the first portion of the second section. The method alsoincludes routing the first portion of the first section through thefirst loop. The method also includes crossing the first portion of thesecond section with the first portion of the first section. The methodalso includes routing the first portion of the second section throughthe second loop.

In some embodiments of the fourth aspect, the method further includesshortening the first loop forming segment and the second loop formingsegment by pulling the first portion of the first section and the firstportion of the second section. In some embodiments of the fourth aspect,the method further includes shortening the first loop and the secondloop by pulling the first portion of the first section and the firstportion of the second section. In some embodiments of the fourth aspect,forming the first coil and the second coil comprises rotating the needlesuch that the second portion of the first section and the second portionof the second section form multiple turns about the exterior of theneedle.

In some embodiments of the fourth aspect, the method further includesdisposing knot rings about the suture and the needle to secure thesuture to the needle. In some embodiments of the fourth aspect, themethod further includes removing the knot rings after forming the firstloop forming segment and the second loop forming segment.

In some embodiments of the fourth aspect, the needle defines an interiorlumen and a distal portion of the needle includes a slot incommunication with the lumen. In further embodiments of the fourthaspect, the method further includes routing proximally the first portionof the first section and the first portion of the second section into adistal end of the interior lumen of the needle. In further embodimentsof the fourth aspect, routing the second portion of the first sectionthrough the interior of the second coil includes routing the secondportion of the first section within the slot of the needle. In furtherembodiments of the fourth aspect, routing the second portion of thesecond section through the interior of the first coil includes routingthe second portion of the second section within the slot of the needle.In further embodiments of the fourth aspect, routing the first portionof the first section through the first loop includes routing the firstportion of the first section into the slot of the needle. In furtherembodiments of the fourth aspect, routing the first portion of thesecond section through the second loop includes routing the firstportion of the second section into the slot of the needle.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features have been described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment. Thus, the disclosed embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cut-away anterior view of a heart, showing the internalchambers, valves and adjacent structures.

FIG. 2A is a top perspective view of a healthy mitral valve with themitral leaflets closed.

FIG. 2B is a top perspective view of a dysfunctional mitral valve with avisible gap between the mitral leaflets.

FIG. 2C is a cross-sectional view of a heart illustrating a mitral valveprolapsed into the left atrium.

FIG. 2D is an enlarged view of the prolapsed mitral valve of FIG. 2C.

FIG. 3 is a cross-sectional view of a heart showing the left atrium,right atrium, left ventricle, right ventricle and the apex region.

FIG. 4 is a schematic illustration of a delivery device, according to anembodiment, shown inserted into a portion of a heart.

FIG. 5 is a schematic illustration of two anchor-tether apparatus shownimplanted within a heart, according to an embodiment.

FIG. 6 is a schematic illustration of a distal anchor delivery device,according to an embodiment, shown in a first configuration prior todeployment of a distal anchor through a mitral leaflet of a heart andshowing the lumen of the outer tube and the lumen of the pusher device.

FIG. 7 is a schematic illustration of the distal anchor delivery deviceof FIG. 6, shown in a first configuration during deployment of a distalanchor through a mitral leaflet of a heart.

FIG. 8 is a schematic illustration of the distal anchor delivery deviceof FIG. 6, shown in a second configuration during deployment of a distalanchor.

FIG. 9 is a schematic illustration of the distal anchor delivery deviceof FIG. 6, shown in a third configuration showing formation of thedistal anchor during deployment.

FIG. 10 is a schematic illustration of the distal anchor delivery deviceof FIG. 6, shown in a fourth configuration showing the delivery devicebeing retracted after deployment of the distal anchor.

FIG. 11 is a perspective view of the distal anchor of FIG. 6 shown in anelongated coiled configuration and disposed about the needle of thedelivery device.

FIG. 12 is a side view of the distal anchor of FIG. 6, shown in a coiledknot configuration.

FIG. 13A is a side view of a single coil/loop variation of the distalanchor of FIG. 6 shown in an elongated coiled configuration; FIG. 13B isa side view of the single coil/loop variation of the distal anchor ofFIG. 13A in a partially coiled knot configuration; and FIG. 13C is aside view of the single coil/loop variation of the distal anchor of FIG.13A in a coiled knot configuration.

FIG. 14A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 14B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a second configuration duringdeployment of a distal anchor through a mitral leaflet of a heart.

FIG. 14C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a third configuration duringdeployment of a distal anchor.

FIG. 14D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 14E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 15A is a cross-sectional side view of a distal anchor deliverydevice, according to another embodiment.

FIG. 15B is an enlarged cross-sectional side view of a portion of thedistal anchor delivery device of FIG. 15A.

FIG. 15C is a perspective view of a distal end portion of the deliverydevice of FIG. 15A

FIG. 15D is a perspective view of a proximal end portion of the deliverydevice of FIG. 15A showing a suture catch of the delivery device in anopen position.

FIG. 16 is a perspective view shown partially in cross-section of thedistal anchor delivery device of FIG. 15A, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 17A is a perspective view shown partially in cross-section of thedistal anchor delivery device of FIG. 15A, shown in a secondconfiguration during deployment of a distal anchor.

FIG. 17B is a side view of a distal end portion of the delivery deviceof FIG. 15A, shown with the distal anchor in a first configuration.

FIG. 18A is a perspective view shown partially in cross-section of thedelivery device of FIG. 15A, shown during deployment of a distal anchor.

FIG. 18B is a side view of a distal end portion of the delivery deviceof FIG. 15A, shown with the distal anchor in a first configuration.

FIG. 19A is a perspective view shown partially in cross-section of thedelivery device of FIG. 15A, shown in a third configuration.

FIG. 19B is a side view of a distal end portion of the delivery deviceof FIG. 15A, showing formation of the distal anchor into a secondconfiguration during deployment.

FIG. 20A is a perspective view shown partially in cross-section of theanchor delivery device of FIG. 15A, shown in a fourth configurationshowing the delivery device being retracted after deployment of thedistal anchor.

FIG. 20B is a side view of a distal end portion of the delivery deviceof FIG. 15A, showing the delivery device being retracted afterdeployment of the distal anchor.

FIG. 21 is a cross-sectional side view the delivery device of FIG. 15A,showing the pusher hub when released from the plunger during deployment.

FIGS. 22A, 22B, and 22C are a side view, a top view in cross-section,and a side view in cross-section, respectively, of a fluid transfersystem of the distal anchor delivery device of FIG. 15A.

FIGS. 23, 24, 25, 26, and 27 illustrate delivery and deployment of adistal anchor using the delivery device of FIG. 15A.

FIG. 28A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 28B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a second configuration duringdeployment of the distal anchor.

FIG. 28C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a third configuration duringdeployment of the distal anchor.

FIG. 28D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 28E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 29A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 29B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a second configuration duringdeployment of the distal anchor.

FIG. 29C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a third configuration duringdeployment of the distal anchor.

FIG. 29D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 29E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 30A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 30B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a second configuration duringdeployment of the distal anchor.

FIG. 30C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a third configuration duringdeployment of the distal anchor.

FIG. 30D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 30E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 31 is a schematic illustration of a distal anchor shown in anelongated configuration, according to an embodiment.

FIGS. 32A, 32B, 32C, 32D, and 32E illustrate in sequence the formationof the distal anchor of FIG. 31 about an exterior of a distal endportion of a delivery device, shown in an elongated configuration.

FIGS. 33A, 33B, 33C, and 33D illustrate an example procedure forpreparing a delivery device to deliver a distal anchor, according to anembodiment.

FIGS. 34A, 34B, 34C, 34D, 34E, 34F, 34G, and 34H illustrate an examplemethod of forming a distal anchor about an exterior of a needle.

FIG. 34I illustrates a distal anchor according to another embodiment,shown in a deployed configuration.

FIG. 34J illustrates a distal anchor according to another embodiment,shown in a deployed configuration and having a flattened base.

FIGS. 34K, 34L, 34M, 34N, 340, 34P, 34Q, 34R, 34S, 34T, 34U, 34V, 34W,34X, 34Y, 34Z, and 34AA illustrate an example method of forming aflattened base distal anchor about an exterior of a needle.

FIG. 35 is a side view of a distal anchor according to anotherembodiment, shown in a first delivery configuration.

FIG. 36 is a side view of the distal anchor of FIG. 35 shown in a seconddeployed configuration.

FIG. 37 is a perspective view of a distal anchor according to anotherembodiment, shown in a delivery configuration.

FIG. 38A is a side view of a distal anchor according to anotherembodiment shown in a first delivery configuration.

FIG. 38B is a side view of the distal anchor of FIG. 38A shown in asecond delivery configuration.

FIGS. 38C and 38D illustrate a side view and a perspective view,respectively, of the distal anchor of FIG. 38A shown in a deployedconfiguration.

FIG. 39A is a side view of a distal anchor according to anotherembodiment shown in a delivery configuration.

FIG. 39B is a side view of the distal anchor of FIG. 39A shown in apartially deployed configuration.

FIG. 39C is a side view of the distal anchor of FIG. 39A in a deployedconfiguration.

FIG. 40A is a side view of a distal anchor according to anotherembodiment shown in a delivery configuration.

FIG. 40B is a side view of the distal anchor of FIG. 40A shown in apartially deployed configuration.

FIG. 40C is a side view of the distal anchor of FIG. 40A in a deployedconfiguration.

FIG. 41A is a side view of a distal anchor according to anotherembodiment, shown in a delivery configuration and disposed within alumen of a delivery device.

FIG. 41B is illustrates the distal anchor of FIG. 41A in the deliveryconfiguration.

FIG. 41C illustrates the distal anchor of FIG. 41A in a partiallydeployed configuration.

FIG. 41D illustrates the distal anchor of FIG. 41A in a deployedconfiguration.

FIGS. 42A and 42B illustrate the distal anchor of FIG. 41A, shown in thedeployed configuration.

FIGS. 43A, 43B, and 43C illustrate a distal anchor according to anotherembodiment, shown in a deployed configuration.

FIG. 44A illustrates a distal anchor according to another embodiment,shown in a delivery configuration.

FIG. 44B illustrates the distal anchor of FIG. 44A, shown with referenceto a valve leaflet and in the delivery configuration.

FIG. 44C illustrates in cross-section the distal anchor of FIG. 44A,shown in the delivery configuration.

FIG. 44D illustrates the distal anchor of FIG. 44A, shown with referenceto the valve leaflet and in a deployed configuration.

FIG. 44E illustrates in cross-section the distal anchor of FIG. 44A,shown with reference to the valve leaflet and in the deployedconfiguration.

FIGS. 45A and 45B are side views of a distal anchor according to anotherembodiment, shown in a delivery configuration and a deployedconfiguration, respectively.

FIG. 45C is a perspective view of the distal anchor of FIGS. 45A and45B, shown in the deployed configuration.

FIG. 46A illustrates a distal anchor according to another embodiment,shown in a in a delivery configuration.

FIG. 46B is a schematic of the distal anchor of FIG. 46A, shown in adeployed configuration.

FIGS. 47A, 47B, and 47C illustrate an example method of repairing aheart valve having a large posterior leaflet.

FIGS. 48A, 48B, and 48C illustrate an example method of repairing aheart valve having a small posterior leaflet.

FIGS. 49A, 49B, 49C, and 49D illustrate an example method of repairing aheart valve by adjusting the annulus and the leaflet.

FIGS. 50, 51, 52, and 53 illustrate representative test results fromprocedures using the method of FIGS. 49A-49D.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

The headings provided herein, if any, are for convenience only and donot necessarily affect the scope or meaning of the claimed invention.

Overview

Apparatus and methods for performing a non-invasive procedure to repaira cardiac valve, such as a mitral valve or tricuspid valve, aredescribed herein. In some embodiments, a method for repairing a mitralvalve includes inserting a delivery device through an apex region (oradjacent to the apex region) of a heart and extending a distal end ofthe delivery device to the proximal side of a leaflet of the mitralvalve. A piercing portion of the delivery device can be used to form anopening in the leaflet, through which the distal end of the deliverydevice can be inserted. The delivery device can be used to form ordeliver a distal anchor to the distal side of the leaflet. The deliverydevice can then be withdrawn and a tether coupled to the distal anchorcan be secured to an outer surface of the heart at the apex region with,for example, a proximal anchor. The combined distal anchor, tether andproximal anchor is also referred to herein as an anchor-tetherapparatus. Before the proximal anchor of the anchor-tether apparatus isfixed to the heart, the length of the tether portion can be adjusted sothat the distal movement during systole of the prolapsed segment of theprolapsed leaflet to which the tether portion is coupled by the distalanchor is limited by the tether apparatus during systole. Properlyadjusting the length of the anchor-tether apparatus while the heart isbeating allows the operator to precisely titrate the position of theprolapsed segment of the prolapsed leaflet in real time to prevent theleaflet from extending above the plane of the annulus (prolapsing), butso that the prolapsed segment of the prolapsed leaflet can move distallyduring systole a sufficient distance to coapt properly with the otherleaflet(s). This adjustment can involve shortening or lengthening thetether portion between the distal and proximal anchors of theanchor-tether apparatus. The same procedure can be repeated on the sameleaflet to deliver one or more additional anchor-tether apparatuses tothe leaflet, and or can be performed on the other leaflet of the mitralvalve to deliver one more anchor-tether apparatuses to the other leaflet(or to both of the other leaflets, in the case of a tricuspid valve). Inthe case of multiple anchor-tether apparatuses, the tether adjustmentprocedure can be done one at a time or all at once with the goal ofmaximizing the surface of coaptation between the leaflets, andeliminating MR.

Placement of the distal anchor can be anywhere in the leaflet from thefree edge up to the base of the leaflet, and/or even in themitral-annular curtain or annulus of the valve. For example, in someembodiments, the anchor-tether apparatus can be placed at or near thevalve annulus. In such embodiments, a method for repairing a mitralvalve includes inserting a delivery device through an apex region (oradjacent to the apex region) of a heart and extending a distal end ofthe delivery device to the ventricular side of the mitral annulus. Apiercing portion of the delivery device can be used to form an openingin the annulus, through which the distal end of the delivery device canbe inserted. The delivery device can be used to form or deliver a distalanchor to the distal or atrial side of the annulus. The delivery devicecan then be withdrawn and a tether coupled to the distal anchor can besecured to an outer surface of the heart at the apex region with, forexample, a proximal anchor. This procedure can be repeated multipletimes at different locations in the annulus to secure multipleanchor-tether apparatus to the valve annulus. In alternativeembodiments, a procedure can include delivering one or more distalanchors to both the annulus and the leaflet, at any of theaforementioned locations.

Before the proximal anchor of the anchor-tether apparatus is fixed tothe apex region of the heart (e.g., between about 1 to about 2 cm basalfrom the true apex of the heart between the LAD and the diagonal), thelength of the tether portion can be adjusted to prevent the annulus frommoving posteriorly during systole. Properly adjusting the length of theanchor-tether apparatus attached to the annulus while the heart isbeating allows the operator to precisely titrate the position of theannulus in real time. This adjustment can involve shortening orlengthening the tether portion between the distal and proximal anchorsof the anchor-tether apparatus. In instances in which multipleanchor-tether apparatus are used, the tether adjustment procedure can bedone one or more at a time or all at once with the goal of optimizingthe positioning of the annulus throughout the cardiac cycle to increaseand/or maximize the amount of leaflet tissue available for coaptation.With one or more anchor-tether apparatus secured to both the mitralvalve leaflet and annulus, the anchor-tether apparatus can be titratedindividually or in groups (e.g., two groups) to apply differentialforces on the leaflet(s) and the annulus.

By accessing the left ventricle from an apex region of the heart that isanterior (between the LAD and the diagonal) and securing the distalanchor(s) to the posterior mitral annulus, the anchor-tether apparatuscreates force vectors that are anteriorly and basally directed pullingthe posterior annulus down into the left ventricle and towards theanterior annulus. When the distal anchor(s) are secured to the mitralannulus, the one or more anchor-tether apparatus replicates the nativevalve's tertiary cords. In some embodiments, the distal anchor(s) can besecured to the body (mid portion) of the leaflet, to replicate secondarycords. Repairing and/or supplementing secondary and/or tertiary cordsduring conventional, on-pump mitral valve operations has not beenreported to date, likely because an annuloplasty ring is traditionallyused, and properly sizing the cords would be too difficult given theflaccidity of the heart. The ability to anchor and adjust primary (oredge), secondary and tertiary cords in real-time under echo guidancegives the operator significantly more opportunity to precisely tailorthe nature of the repair based on a patient's specific anatomy.

In some embodiments, a delivery device is provided to perform the aboverepair procedures. Such a delivery device can include, for example adistal end portion that includes a piercing portion and a supportportion, an elongate member that can be steered in one or more planesand is coupled to the distal end portion, and an actuating handlecoupled to a proximal end portion of the elongate member. The piercingportion of the distal end portion of the delivery device can be used toform the opening in the leaflet of the mitral valve. The support portionof the distal end portion can be used to deliver or form the distalanchor. The handle can include a tether control device that can be usedto hold the tether extending from the distal anchor and secure thetether to the apex region with the proximal anchor.

In some embodiments, an apparatus includes a handle coupled to asteerable outer tube, an actuator operably coupled to the handle, apusher device movably disposed within a lumen of the outer tube, apuncture member coupled to the actuator and at least partially disposedwithin a lumen defined by the pusher device, and a distal anchor. Thedistal anchor is disposed at a distal end portion of an artificialchordae and disposed in a delivery configuration within a distal endportion of the lumen of the outer tube. The outer tube can be rigid andstraight or steerable in one or more planes. The artificial chordae hasa proximal end portion coupled to the actuator. The proximal end portionof the artificial chordae extends through a lumen defined by thepuncture member. The actuator can be actuated at a first time periodsuch that (1) the puncture member is moved distally a preset distancefrom the distal end of the delivery device, and (2) the pusher device ismoved distally such that at least a portion of the distal anchor ismoved distally relative to the puncture member and disposed distal tothe distal end of the puncture member.

In some embodiments, an apparatus includes a handle, an actuatoroperably coupled to the handle, a pusher device defining a lumen, apuncture member coupled to the actuator and at least partially disposedwithin the lumen defined by the pusher device, and a distal anchor. Thedistal anchor is disposed at a distal end portion of an artificialchordae and disposed in a delivery configuration. The artificial chordaehas a proximal end portion coupled to the actuator. The proximal endportion of the artificial chordae extends through a lumen defined by thepuncture member. The actuator can be actuated to move the puncturemember distally a preset distance and to move the pusher device distallyto move the distal anchor distal to the distal end of the puncturemember and to move the distal anchor from the delivery configuration toa deployed configuration.

In some embodiments, a method includes inserting a distal end portion ofa delivery device through an apex region of a heart, through a ventricleof the heart and to a proximal side of a valve leaflet. The deliverydevice has a distal anchor disposed in a delivery configuration at adistal end portion of the delivery device. A distal end of the deliverydevice is positioned in contact with the proximal side of the leaflet ofthe valve. The delivery device is actuated to move the puncture memberdistally through the leaflet a preset distance outside the distal end ofthe delivery device and on a distal side of the leaflet. The puncturemember forms, creates or otherwise defines an opening in the leaflet asthe puncture member is moved through the leaflet. The distal anchor isdisposed at a distal end portion of an artificial chordae. Theartificial chordae extends through a lumen of the puncture member andhas a proximal end portion coupled to the delivery device. The actuatingthe delivery device includes moving the distal anchor distally relativeto the puncture member to move the distal anchor to a deployedconfiguration.

In some embodiments, an apparatus includes a handle, an actuatoroperably coupled to the handle, a pusher device defining a lumen, apuncture member coupled to the actuator and at least partially disposedwithin a lumen defined by the pusher device, and a distal anchor. Thedistal anchor is disposed at a distal end portion of an artificialchordae and disposed in a delivery configuration. The artificial chordaehas a proximal end portion coupled to the handle. The proximal endportion of the artificial chordae extends through a lumen defined by thepuncture member. The actuator can be actuated at a first time period tomove the puncture member distally a preset distance and to move thepusher device distally such that at least a portion of the distal anchoris moved distally relative to the puncture member and disposed distal tothe distal end of the puncture member. The actuator can be actuated at asecond time period after the first time period to move the distal anchorfrom its delivery configuration to a deployed configuration.

In some embodiments, a method includes inserting a distal end portion ofa delivery device through an apex region of a heart, through a ventricleof the heart and to a proximal side of a valve leaflet. The deliverydevice has a distal anchor disposed in a delivery configuration at adistal end portion of the delivery device. A distal end of the deliverydevice is positioned in contact with the proximal side of the leaflet ofthe valve. The delivery device is actuated during a first time period tomove the puncture member distally through the leaflet a preset distanceoutside the distal end of the delivery device and on a distal side ofthe leaflet. The puncture member forms, creates, or otherwise defines anopening in the leaflet as the puncture member is moved through theleaflet. The distal anchor is disposed at a distal end portion of anartificial chordae that extends through a lumen of the puncture memberand has a proximal end portion coupled to the actuator. Actuating thedelivery device during the first time period moves the distal anchordistally relative to the puncture member, through the opening in theleaflet such that at least a portion of the distal anchor is disposeddistal to the distal end of the puncture member. The delivery device isactuated during a second time period after the first time period to movethe proximal end portion of the artificial chordae proximally causingthe distal anchor to move to a deployed configuration.

As illustrated in FIG. 1, the human heart 10 has four chambers, whichinclude two upper chambers denoted as atria 12, 16 and two lowerchambers denoted as ventricles 14, 18. A septum 20 (see, e.g., FIG. 3)divides the heart 10 and separates the left atrium 12 and left ventricle14 from the right atrium 16 and right ventricle 18. The heart furthercontains four valves 22, 23, 26, and 27. The valves function to maintainthe pressure and unidirectional flow of blood through the body and toprevent blood from leaking back into a chamber from which it has beenpumped.

Two valves separate the atria 12, 16 from the ventricles 14, 18, denotedas atrioventricular valves. The mitral valve 22, also known as the leftatrioventricular valve, controls the passage of oxygenated blood fromthe left atrium 12 to the left ventricle 14. A second valve, the aorticvalve 23, separates the left ventricle 14 from the aortic artery (aorta)29, which delivers oxygenated blood via the circulation to the entirebody. The aortic valve 23 and mitral valve 22 are part of the “left”heart, which controls the flow of oxygen-rich blood from the lungs tothe body. The right atrioventricular valve, the tricuspid valve 24,controls passage of deoxygenated blood into the right ventricle 18. Afourth valve, the pulmonary valve 27, separates the right ventricle 18from the pulmonary artery 25. The right ventricle 18 pumps deoxygenatedblood through the pulmonary artery 25 to the lungs wherein the blood isoxygenated and then delivered to the left atrium 12 via the pulmonaryvein. Accordingly, the tricuspid valve 24 and pulmonic valve 27 are partof the “right” heart, which control the flow of oxygen-depleted bloodfrom the body to the lungs.

Both the left and right ventricles 14, 18 constitute “pumping” chambers.The aortic valve 23 and pulmonic valve 27 lie between a pumping chamber(ventricle) and a major artery and control the flow of blood out of theventricles and into the circulation. The aortic valve 23 and pulmonicvalve 27 have three cusps, or leaflets, that open and close and therebyfunction to prevent blood from leaking back into the ventricles afterbeing ejected into the lungs or aorta 29 for circulation.

Both the left and right atria 12, 16 are “receiving” chambers. Themitral valve 22 and tricuspid valve 24, therefore, lie between areceiving chamber (atrium) and a ventricle so as to control the flow ofblood from the atria to the ventricles and prevent blood from leakingback into the atrium during ejection from the ventricle. Both the mitralvalve 22 and tricuspid valve 24 include two or more cusps, or leaflets(not shown in FIG. 1), that are encircled by a variably dense fibrousring of tissues known as the annulus (not shown in FIG. 1). The valvesare anchored to the walls of the ventricles by chordae tendineae(chordae) 17. The chordae tendineae 17 are cord-like tendons thatconnect the papillary muscles 19 to the leaflets (not shown in FIG. 1)of the mitral valve 22 and tricuspid valve 24 of the heart 10. Thepapillary muscles 19 are located at the base of the chordae tendineae 17and are within the walls of the ventricles. The papillary muscles 19 donot open or close the valves of the heart, which close passively inresponse to pressure gradients; rather, the papillary muscles 19 bracethe valves against the high pressure needed to circulate the bloodthroughout the body. Together, the papillary muscles 19 and the chordaetendineae 17 are known as the subvalvular apparatus. The function of thesubvalvular apparatus is to keep the valves from prolapsing into theatria when they close.

The mitral valve 22 is illustrated in FIG. 2A. The mitral valve 22includes two leaflets, the anterior leaflet 52 and the posterior leaflet54, and a diaphanous incomplete ring around the valve, called theannulus 53. The mitral valve 22 has two papillary muscles 19, theanteromedial and the posterolateral papillary muscles (see, e.g., FIG.1), which attach the leaflets 52, 54 to the walls of the left ventricle14 via the chordae tendineae 17 (see, e.g., FIG. 1).

FIG. 2B illustrates a prolapsed mitral valve 22. As can be seen withreference to FIG. 2B-2D, prolapse occurs when a prolapsed segment of aleaflet 52, 54 of the mitral valve 22 is displaced above the plane ofthe mitral annulus into the left atrium 12 (see FIGS. 2C and 2D)preventing the leaflets from properly sealing together to form thenatural plane or line of coaptation between the valve leaflets duringsystole. Because one or more of the leaflets 52, 54 malfunction, themitral valve 22 does not close properly, and, therefore, the leaflets52, 54 fail to coapt. This failure to coapt causes a gap 55 between theleaflets 52, 54 that allows blood to flow back into the left atrium,during systole, while it is being ejected by the left ventricle. As setforth above, there are several different ways a leaflet may malfunction,which can thereby lead to regurgitation.

Mitral valve regurgitation increases the workload on the heart and maylead to very serious conditions if left un-treated, such as decreasedventricular function, pulmonary hypertension, congestive heart failure,permanent heart damage, cardiac arrest, and ultimately death. Since theleft heart is primarily responsible for circulating the flow of bloodthroughout the body, malfunction of the mitral valve 22 is particularlyproblematic and often life threatening.

As described in detail in PCT International Application No.PCT/US2012/043761 (published as WO 2013/003228 A1) (referred to hereinas “the '761 PCT Application”), the entire disclosure of which isincorporated herein by reference, methods and devices are provided forperforming non-invasive procedures to repair a cardiac valve, such as amitral valve. Such procedures include procedures to repair regurgitationthat occurs when the leaflets of the mitral valve do not coapt at peakcontraction pressures, resulting in an undesired back flow of blood fromthe ventricle into the atrium. As described in the '761 PCT Application,after the malfunctioning cardiac valve has been assessed and the sourceof the malfunction verified, a corrective procedure can be performed.Various procedures can be performed in accordance with the methodsdescribed therein to effectuate a cardiac valve repair, which willdepend on the specific abnormality and the tissues involved.

In one example method, the heart may be accessed through one or moreopenings made by a small incision(s) in a portion of the body proximalto the thoracic cavity, for example, between one or more of the ribs ofthe rib cage of a patient, proximate to the xiphoid appendage, or viathe abdomen and diaphragm. Access to the thoracic cavity may be soughtso as to allow the insertion and use of one or more thorascopicinstruments, while access to the abdomen may be sought so as to allowthe insertion and use of one or more laparoscopic instruments. Insertionof one or more visualizing instruments may then be followed bytransdiaphragmatic access to the heart. Additionally, access to theheart may be gained by direct puncture (e.g., via an appropriately sizedneedle, for instance an 18-gauge needle) of the heart from the xiphoidregion. Accordingly, the one or more incisions should be made in such amanner as to provide an appropriate surgical field and access site tothe heart. Access may also be achieved using percutaneous methods. Seefor instance, “Full-Spectrum Cardiac Surgery Through a Minimal IncisionMini-Sternotomy (Lower Half) Technique”, Doty et al. Annals of ThoracicSurgery 1998; 65(2): 573-7 and “Transxiphoid Approach Without MedianSternotomy for the Repair of Atrial Septal Defects”, Barbero-Marcial etal. Annals of Thoracic Surgery 1998; 65(3): 771-4, which areincorporated in their entirety herein by reference.

After prepping and placing the subject under anesthesia, atransesophageal echocardiogram (TEE) (2D or 3D), a transthoracicechocardiogram (TTE), intracardiac echo (ICE), or cardio-optic directvisualization (e.g., via infrared vision from the tip of a 7.5 Fcatheter) may be performed to assess the heart and its valves.

After a minimally invasive approach is determined to be advisable, oneor more incisions are made proximate to the thoracic cavity so as toprovide a surgical field of access. The total number and length of theincisions to be made depend on the number and types of the instrumentsto be used as well as the procedure(s) to be performed. The incision(s)should be made in such a manner so as to be minimally invasive. Asreferred to herein, the term “minimally invasive” means in a manner bywhich an interior organ or tissue may be accessed with as little aspossible damage being done to the anatomical structure through whichentry is sought. Typically, a minimally invasive procedure is one thatinvolves accessing a body cavity by a small incision of, for example,approximately 5 cm or less made in the skin of the body. The incisionmay be vertical, horizontal, or slightly curved. If the incision isplaced along one or more ribs, it should follow the outline of the rib.The opening should extend deep enough to allow access to the thoraciccavity between the ribs or under the sternum and is preferably set closeto the rib cage and/or diaphragm, dependent on the entry point chosen.

One or more other incisions may be made proximate to the thoracic cavityto accommodate insertion of a surgical scope so as to allow ready accessto and visualization of the heart. The surgical scope may be any type ofendoscope, but is typically a thorascope or laparoscope, dependent uponthe type of access and scope to be used. At this point, the practitionercan confirm that access of one or more cardiac valves through the apexregion of the heart is appropriate for the particular procedure to beperformed.

Once a suitable entry point has been established, the surgeon can useone or more sutures to make a series of stiches in one or moreconcentric circles in the myocardium at the desired location to create a“pursestring” closure. The Seldinger technique can be used to access theleft ventricle in the area surrounded by the pursestring suture bypuncturing the myocardium with a small sharp hollow needle (a “trocar”)with a guidewire in the lumen of the trocar. Once the ventricle has beenaccessed, the guidewire can be advanced, and the trocar removed. Avalved-introducer with dilator extending through the lumen of thevalved-introducer can be advanced over the guidewire to gain access tothe left ventricle. The guidewire and dilator can be removed and thevalved-introducer will maintain hemostasis, with or without a suitabledelivery device inserted therein, throughout the procedure.Alternatively, the surgeon can make a small incision in the myocardiumand insert the valved-introducer into the heart via the incision. Oncethe valved-introducer is properly placed the pursestring suture istightened to reduce bleeding around the shaft of the valved-introducer.

A suitable device such as a delivery device described herein, may beadvanced into the body and through the valved-introducer in a manner soas to access the left ventricle. The advancement of the device may beperformed in conjunction with sonography or direct visualization (e.g.,direct transblood visualization). For example, the delivery device maybe advanced in conjunction with TEE guidance or ICE so as to facilitateand direct the movement and proper positioning of the device forcontacting the appropriate apical region of the heart. Typicalprocedures for use of echo guidance are set forth in Suematsu, Y., J.Thorac. Cardiovasc. Surg. 2005; 130:1348-1356, herein incorporated byreference in its entirety.

As shown in FIG. 3, one or more chambers, e.g., the left atrium 12, leftventricle 14, right atrium 16, or right ventricle 18 in the heart 10 maybe accessed in accordance with the methods disclosed herein. Access intoa chamber 12, 14, 16, 18 in the heart 10 may be made at any suitablesite of entry but is preferably made in the apex region of the heart,for example, slightly above the apex 26 at the level of the papillarymuscles 19 (see also FIG. 2C). Typically, access into the left ventricle14, for instance, to perform a mitral valve repair, is gained throughthe process described above performed in the apical region, close to (orslightly skewed toward the left of) the median axis 28 of the heart 10.Typically, access into the right ventricle 18, for instance, to performa tricuspid valve repair, is gained through the process described aboveperformed in the apical region, close to or slightly skewed toward theright of the median axis 28 of the heart 10. Generally, an apex regionof the heart is a bottom region of the heart that is within the left orright ventricular region and is below the mitral valve 22 and tricuspidvalve 24 and toward the tip or apex 26 of the heart 10. Morespecifically, an “apex region” AR of the heart (see FIGS. 2C and 3) iswithin a few centimeters to the right or to the left of the septum 20 ofthe heart 10 at or near the level of the papillary muscles 19.Accordingly, the ventricle can be accessed directly via the apex 26, orvia an off-apex location that is in the apical or apex region AR, butslightly removed from the apex 26, such as via a lateral ventricularwall, a region between the apex 26 and the base of a papillary muscle19, or even directly at the base of a papillary muscle 19 or above.Typically, the incision made to access the appropriate ventricle of theheart is no longer than about, for example, 0.5 cm. Alternatively,access can be obtained using the Seldinger technique described above.

The mitral valve 22 and tricuspid valve 24 can be divided into threeparts: an annulus (see 53 in FIGS. 2A and 2B), leaflets (see 52, 54 inFIGS. 2A and 2B), and a sub-valvular apparatus. The sub-valvularapparatus includes the papillary muscles 19 (see FIG. 1) and the chordaetendineae 17 (see FIG. 1), which can elongate and or rupture. If thevalve is functioning properly, when closed, the free margins or edges ofthe leaflets come together and form a tight junction, the arc of which,in the mitral valve, is known as the line, plane or area of coaptation(see, e.g., encircled area labeled AC in FIG. 27). Normal mitral andtricuspid valves open when the ventricles relax allowing blood from theatrium to fill the decompressed ventricle. When the ventricle contracts,chordae tendineae properly position the valve leaflets such that theincrease in pressure within the ventricle causes the valve to close,thereby preventing blood from leaking into the atrium and assuring thatall of the blood leaving the ventricle is ejected through the aorticvalve (not shown) and pulmonic valve (not shown) into the arteries ofthe body. Accordingly, proper function of the valves depends on acomplex interplay between the annulus, leaflets, and subvalvularapparatus. Lesions in any of these components can cause the valve todysfunction and thereby lead to valve regurgitation. As set forth above,regurgitation occurs when the leaflets do not coapt properly at peakcontraction pressures. As a result, an undesired back flow of blood fromthe ventricle into the atrium occurs.

Although the procedures described herein are with reference to repairinga cardiac mitral valve or tricuspid valve by the implantation of one ormore artificial chordae, the methods presented are readily adaptable forvarious types of leaflet and annular repair procedures. In general, themethods herein will be described with reference to a mitral valve 22.

Example Distal Anchors and Associated Delivery Devices and Methods

Some embodiments described herein refer to a delivery device thatincludes a needle as a puncture member configured to pierce a cardiactissue such as a mitral valve leaflet. It should be understood thatalthough such embodiments are described with reference to a needle, inalternative embodiments, a delivery device can include any puncturemember suitable to pierce a cardiac tissue and form an openingtherethrough. For example, in some embodiments, a puncture member can bea trocar, guidewire, rod, tube, or the like. As a further example, insome embodiments, a puncture member can include an electrosurgicaldevice, e.g., a device with an electrical circuit (or any suitableelectrical energy source) operating at a frequency (e.g., a highfrequency) configured to cut and/or pierce cardiac tissue.

Some embodiments described herein refer to a delivery device thatincludes a plunger as an actuator configured to receive a manual forceand move within a handle of the delivery device to help deliver anddeploy a distal anchor within a heart. For example, in some embodiments,such a delivery device having a manual plunger actuator can be used todeploy a bulky-knot type distal anchor as described herein. It should beunderstood that although such embodiments are described with referenceto a manually actuated plunger, in alternative embodiments, a deliverydevice can include any suitable actuator, such as, for example, anautomatically actuated plunger, and/or a button that when pressed orotherwise activated can actuate an internal mechanism suitable toselectively move components (e.g., a pusher, a puncture member, asuture, etc.) of the delivery device. As a further example, an actuatorof a delivery device can include one or more energy storage membersconfigured to selectively move components of the delivery device.

In some embodiments, a method includes the implantation of one or moreartificial chordae tendineae into one or more leaflets (e.g., 52, 54 inFIGS. 2A and 2B) of a malfunctioning mitral valve 22 and/or tricuspidvalve 24. After an appropriate incision has been made in the apex regionof the heart, for example, in the apex 26, a delivery device can beintroduced into, for example, the left ventricle 14 of the heart andadvanced in such a manner so as to contact one or more cardiac tissues(for instance, a leaflet, an annulus, a cord, a papillary muscle, or thelike) that are in need of repair. Sonic guidance, for instance, TEEguidance or ICE, may be used to assist in the advancement of the deviceinto the ventricle, the proper positioning of the distal tip of thedevice on the proximal side of the leaflet and, if necessary, thegrasping of the cardiac tissue with the device. Direct trans-bloodvisualization may also be used.

FIG. 4 is a schematic illustration of a portion of a heart with adelivery device inserted therein, according to an embodiment. Thedelivery device 130 can include a distal end portion 132 configured tobe inserted into a heart H, an elongate portion 134 coupled to thedistal end portion 132, and a proximal end portion 136. The distal endportion 132 of the delivery device 130 can include a puncture orpiercing member (not shown) and an anchor support portion (not shown).The distal end portion 132 can include other features to enable thedelivery device 130 to perform various functions, such as, for example,grasping, suctioning, irrigating, cutting, suturing, or otherwiseengaging a cardiac tissue.

The proximal end portion 136 can include, for example, a handle that canbe used by the user/operator to manipulate movement of the deliverydevice 130 and/or to actuate the delivery device 130. The proximal endportion 136 can also include control features and/or components that canbe used to actuate various functions of the delivery device 130. Theproximal end portion 136 can also include a holding device or memberthat can be used to hold and control a tether (e.g., suture, cord orwire) extending from a distal anchor (described in more detail below)during deployment of the distal anchor.

Using, for example, ultrasound guidance (real-time transesophagealechocardiography), the delivery device 130 can be inserted through anaccess port at the apex Ap (or near the apex) of the heart H and guidedthrough the left ventricle LV and into contact with a proximal side of amitral valve leaflet L1 (or L2), shown in FIGS. 4 and 5, at a locationwhere the user/operator has determined that a repair is needed.Typically, this would be a prolapsed segment of the body of the anterioror posterior leaflet, e.g., in a location where the valve has prolapsedas a result of a broken or elongated cord. The distal end portion 130 ofthe delivery device 130 can be used to puncture or form an opening inthe valve leaflet L1 and/or the valve leaflet L2. For example, as shownin FIG. 4, the piercing member at a distal tip 138 can be used topuncture or pierce through the leaflet L2. This can be done with orwithout grasping, capturing, or otherwise immobilizing the prolapsedsegment of the leaflet.

The distal tip 138 of the delivery device 130 can be inserted throughthe puncture site or opening and positioned on a distal side of theleaflet L2 and within the left atrium LA. When the distal tip 138 is inthe desired position, the delivery device 130 can be actuated to inserta distal anchor 140 or form a distal anchor 140 (see FIG. 5) on thedistal side of the leaflet L2 within the left atrium LA of the heart H.In some embodiments, the distal anchor 140 can include a suture or asuture/guide wire combination that can form into a knot upon actuationof the delivery device 130. For example, in some embodiments, the distalanchor 140 includes a large or bulky knot made of ePTFE suture or otherappropriate material that is formed by the delivery device 130 and thatattains a significant size in the left atrium LA, above the leaflet L2.The knot can be in the form of one or more multi-turn coils of thesuture or other material used to form the tether (described in moredetail below), which coils can be changed from an elongatedconfiguration to a knot configuration by approximating opposite ends ofthe coil(s) towards each other, to form one or more loops. In someembodiments, the distal anchor 140 includes an anchor member that isdeployed into the left atrium LA above the leaflet L2 upon actuation ofthe delivery device 130.

The distal anchor 140, whether formed by the delivery device 130 ordeployed by the delivery device 130 can be coupled to a tether 142extending proximally from the distal anchor 140 and secured to theproximal end portion 136 of the delivery device 130. Alternatively, thedistal anchor 140 and the tether 142 can be all one component (e.g.,ePTFE suture) where the distal anchor 140 is formed by altering theshape of the tether 142 from a first position to a second position. Asdescribed above, the proximal end portion 136 of the delivery device 130can include a holding device (not shown) that can be used to secure andcontrol the tether 142 during delivery and deployment of the distalanchor 140.

As shown in FIG. 5, after the distal anchor 140 has been deployed orformed, the delivery device 130 can be withdrawn from the heart H. Thelength of the tether 142 between the distal anchor 140 and the openingin the heart can be adjusted, as discussed above, until the desiredlength is established (e.g., prolapse of the leaflet is prevented, butthe leaflet can still move distally sufficient to coapt with the otherleaflet(s)). The proximal end of the tether 142 can then be secured toan outer surface of the heart, H, at, for example, the apex Ap region,with a proximal anchor 144. The proximal anchor 144 can be, for example,a pledget, one or more knots, or other suitable anchoring device.

The above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet L1 in the samemanner. The result can thus be that two or more anchor-tetherapparatuses 145 are each anchored on a distal side of a leaflet L1, L2with a distal anchor 140 and secured to the apex Ap region of the heartH with a proximal anchor 144 via the tether 142. Thus, eachanchor-tether apparatus 145 can secure the top of the leaflet L1, L2 tothe apex Ap region of the heart H, functioning as an artificial chordaeor cord.

FIGS. 6-10 show a schematic illustration of an embodiment of a distalanchor that can be deployed on a distal side of a mitral valve leaflet,and a delivery device for deploying such a distal anchor within theheart of a patient. In this embodiment, a distal anchor 240 (see, e.g.,FIGS. 9 and 10) includes a pre-formed knot that can be formed/deployedusing a delivery device 230. As shown in FIG. 6, the delivery device 230includes a distal portion 232, a medial portion 234, and a proximal endportion 236. Disposed on the distal end portion 232 is a distal endeffector 233 that is coupled to a distal end portion of an elongateouter tube 231 and can be placed in contact with a proximal side of amitral valve leaflet L during deployment of the distal anchor 240. Thedistal end effector 233 can distribute the force of the elongate outertube 231 over a larger area to prevent/eliminate puncturing of theleaflet with the delivery device 230 during deployment. In someembodiments, the end effector 233 can include a balloon. A proximal endportion of the outer tube 231 is coupled to a handle 235 at the proximalend portion 236. Coupled to or included at least partially within thehandle 235 are an elongate pusher 237 coupled to a pusher hub 239, apuncture member 241 (e.g., a needle) coupled to a puncture member hub243 (e.g., a needle hub), and a suture catch 246. The pusher 237 ismovably disposed within a lumen of the outer tube 231 and the needle 241is movably disposed within a lumen of the pusher 237. The needle 241includes at a distal end a piercing member or portion 247 as shown inFIG. 7. In some embodiments, the elongate outer tube 231 can provide arelatively stiff structure and can protect the puncture member 241and/or the pusher 237 during delivery and deployment of the distalanchor, and during withdrawal of the delivery device from within thepatient. In other embodiments, the delivery device does not include anelongate outer tube or distal end effector. In such embodiments, in someinstances, a separate device can be used to provide functionalitysimilar to the functionality provided by the elongate outer tube 231 andthe distal end effector 233 described above.

A suture 242 (also referred to herein as “tether”) is coupled to thesuture catch 246 and extends through a lumen of the needle 241 and isformed into a coiled configuration at the distal end portion 232 of thedelivery device 230 as shown in FIG. 6. The suture catch 246 can beconfigured to releasably hold or secure the suture 242 during deliveryof the distal anchor 240 as described in more detail below. In someembodiments, the suture catch 246 can hold the suture 242 with afriction fit or with a clamping force and can have a lock that can bereleased after the distal anchor 240 has been deployed/formed. Thedistal coiled portion of the suture 242 will be formed into the distalanchor 240 upon actuation of the delivery device 230 as described inmore detail below. As discussed above for distal anchor 140, the distalanchor 240 (e.g., bulky knot) can be in the form of one or moremulti-turn coils of the suture 242 that can be changed from an elongatedconfiguration during delivery (see, e.g., FIGS. 7, 11, and 13A) to aknot configuration (see, e.g., FIGS. 9, 10, 12 and 13C) by approximatingopposite ends of the coil(s) towards each other, to form one or moreloops. For example, two strands or lengths of the suture 242 extend fromopposite ends of the elongate coiled portion of the suture 242 andextend through the delivery device 230. When the two proximal ends ofthe suture 242 are pulled proximally, the opposite ends of the coiledportions are pulled towards each other to form the loops.

FIGS. 13A-13C illustrate the sequence described above with respect tothe distal anchor 140 and the distal anchor 240 transitioning from anelongated configuration to a knot configuration, however for ease ofillustration, a single coil and loop variation is shown and described.As shown in FIG. 13A, the distal anchor 240′ is in a coiled, elongatedformation (e.g., a preformed knot) configured for delivery to a heart.To form the knot configuration (as shown in FIG. 13C), a proximal end ofthe suture 242′ is pulled proximally to deflect the distal end DE of thecoil laterally with respect to the proximal end PE of the coil and todraw the proximal end PE of the coil and the distal end DE of the coiltowards each other to form a loop L, as illustrated in FIGS. 13B and13C.

To deliver and form the distal anchor 240 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion ofthe needle 241 of the delivery device 230 can be inserted through anapex portion of the heart and into the left ventricle until the endeffector 233 contacts a proximal side of the mitral valve leaflet L asshown in FIGS. 6-9. With the delivery device 230 positioned against themitral leaflet L, and with a proximal end portion of the suture 232(e.g., the two proximal end portions of the suture 242) secured to thesuture catch 246, the needle 241 and needle hub 243, the pusher 237 andpusher hub 239, and the suture catch 246 are all moved distally (in thedirection of arrow A) relative to the handle 235 as shown in FIG. 7,until the pusher 237 and pusher hub 239 locks into place relative to thehandle 235. As these components are collectively moved distally, thepiercing portion 247 of the needle 241 punctures the leaflet L formingan opening, and is passed through the leaflet L and is disposed on thedistal side of the leaflet L. In some embodiments, the distal end ofpiercing portion 247 extends outside of the end effector 233 of thedelivery device 230 about 2.5 cm (about 1 inch). Simultaneously, thepusher 237 pushes or moves the distal anchor 240 (e.g., the distalcoiled portion of the suture 232), still in an elongated configurationand surrounding a portion of the needle 241, through the opening in theleaflet L until it is disposed on the distal side of the leaflet L. Asshown in FIG. 7, the piercing portion 247 of the needle 241 extendsbeyond the distal anchor 240.

As shown in FIG. 8, the needle 241 and needle hub 243 can then bewithdrawn or moved proximally in the direction of arrow B until contactis made between the needle hub 243 and the suture catch 246, leaving thedistal anchor 240 in the left atrium on the distal side of the leafletL. As the needle hub 243 (and needle 241) continue to be movedproximally in the direction of arrow B, the distal anchor 240 will beginto form a knot because the suture 242 (e.g., the two end portions ofsuture 242) is secured to the suture catch 246 such that as the suturecatch 246 is moved proximally it pulls the distal anchor 240approximating opposite ends of the coils towards each other to form oneor more loops as show in FIGS. 9 and 10. Further, there is a length ofsuture 242 between the suture catch 246 and the proximal end of theneedle 241 which allows the suture 242 to slide off the needle 241before the knot is formed. When the needle 241 is withdrawn, the wrapsof the suture 242 stay in the same place, eliminating the extra lengthof suture 242 between the distal end of the needle 241 and the suturecatch 246. The knot is thus formed on a distal end of the pusher 237 andnot against the mitral valve leaflets. After the distal anchor 240 hasformed a knot (as in FIGS. 9 and 10), the proximal end portions of thesuture 242 can be released from the suture catch 246 and the deliverydevice 230 can be withdrawn proximally in the direction of arrow B,leaving the distal anchor 240 disposed on the distal side of the leafletL, and two lengths of the suture 242 extending out of the heart. Inother words, with the suture 242 released from the suture catch 246, thedelivery device 230 can be slid over the suture 242 for removal.

As described above for distal anchor 140 and tether 142, the length ofthe suture 242 between the distal anchor 240 and the opening in theheart can be adjusted, as discussed above, until the desired length isestablished (e.g., prolapse of the leaflet is prevented, but the leafletcan still move distally sufficient to coapt with the other leaflet(s)).The proximal ends of the suture 242 can then be secured to an outersurface of the heart at, for example, the apex region, with a proximalanchor (not shown). The proximal anchor can be, for example, a pledget,one or more knots, or other suitable anchoring device. As previouslydescribed, the above procedure can be performed multiple times on thesame leaflet, and/or can be performed on the other mitral valve leafletin the same manner. The result can thus be that one or moreanchor-tether apparatuses (e.g., anchor-tether apparatus 145) asdescribed above are each anchored on a distal side of a leaflet with adistal anchor and secured to the apex of the heart with a proximalanchor via the suture 242. Alternatively, if one or more anchor-tetherapparatus is attached to both mitral valve leaflets, an anchor-tetherapparatus attached to each leaflet can be secured together in the heartby tying them together with knots or by another suitable attachmentmember (not shown), creating an edge-to-edge repair to decrease theseptal-lateral distance of the mitral valve orifice. The two attachedanchor-tether apparatus can be left loose or tensioned to create a“facilitated” edge-to-edge repair before being secured to an outersurface of the heart with a proximal anchor.

FIGS. 6-10 illustrate one example method and device for deploying abulky knot distal anchor. In another embodiment, a bulky knot distalanchor can be deployed/formed using a delivery device that utilizes ashort throw deployment sequence configured to insert the distal endportion and piercing member of the needle a shorter distance into theleft atrium than as shown and described above for the embodiment ofFIGS. 6-10. In such an embodiment, the distal end portion of the needleis used to puncture the leaflet tissue and form an opening in theleaflet tissue, but does not extend as far into the left atrium. In someembodiments, the needle can be extended outside of the distal end of thedelivery device (e.g., beyond the end effector) half the distance thanwhat is shown and described for the embodiment of FIGS. 6-10. Forexample, in some embodiments, the needle can be extended outside thedelivery device a distance of about 5-8 mm (about 0.2-0.3 inches) (e.g.,about 6 mm (about 0.25 inches)). In other embodiments, the needle can beextended outside the delivery device a distance of about 4-10 mm (about0.15-0.4 inches). Similarly, in some embodiments, a needle can beextended through a proximal side of a heart valve leaflet a distance,for example, of about 5-8 mm (about 0.2-0.3 inches) or a distance ofabout 4-10 mm (about 0.15-0.4 inches) from the proximal side of theheart valve leaflet. As yet a further example of the short throwdeployment sequence, the needle can be moved a distance sufficient topierce the proximal side of the leaflet and extend a distance of about1-6 mm (about 0.05-0.25 inches (e.g., about 2.5 mm (about 0.1 inch))from and distal to the distal side of the leaflet. The distal coiledportion of the suture is then moved distally over the needle and intothe left atrium using a pusher device. By shortening the distance inwhich the needle is extended outside of the end effector and into theleft atrium, the potential for damage to surrounding tissue can bereduced or eliminated. Further, in some cases, such a short throwdeployment sequence can help limit or prevent damage to the needleitself. For example, in some cases, if the needle is extended too fardistally outside of the outer tube, the needle may bend unwantedly.FIGS. 14A-14E are schematic illustrations of an embodiment of a deliverydevice for delivering and deploying a distal anchor and configured toprovide such a short throw deployment sequence.

As shown in FIGS. 14A-14E, a delivery device 330 includes a distal endportion 332, a proximal end portion 336 and a medial portion 334. Thedistal end portion 332 can include an end effector 333 that can beplaced in contact with a leaflet L of a mitral valve as described above.The end effector 333 can be coupled to a distal end portion of an outertube 331 and a proximal end portion of the outer tube 331 is coupled toa handle 335 at the proximal end portion 336. The end effector 333 candistribute the force of the outer tube 331 over a larger area toprevent/eliminate puncturing of the leaflet with the delivery device 330during deployment. In some embodiments, the end effector 333 can includea balloon. An elongate pusher 337 is movably disposed within a lumen ofthe outer tube 331 and is coupled to a pusher hub 339 that is movablydisposed within the handle 335 and releasably coupled to a plunger (notshown). A needle 341 (see FIGS. 14C and 14D) is movably disposed withina lumen of the pusher 337 and is coupled to a needle hub 243 that isalso coupled to the plunger (not shown). The plunger is used to actuateor move the needle 341 and the pusher 337 during deployment of a distalanchor 340 and can be movably disposed at least partially within thehandle 335 as described in more detail below for delivery device 430.For example, the handle 335 defines a lumen in which the plunger can bemoved. During operation, the pusher 337 also moves within the lumen ofthe handle 335 as described in more detail below. The delivery device330 can also include a locking lever (not shown) that can be used toprevent the plunger from moving within the handle 335 during storage andprior to performing a procedure to deploy the distal anchor.

A suture catch 346 (also referred to as “tether catch”) is also coupledto the plunger at a proximal end of the delivery device 330. The suturecatch 346 can be configured to releasably hold or secure a suture 342extending through the delivery device 330 during delivery of the distalanchor 340 as described above and as described in more detail below withreference to delivery device 430. In some embodiments, the suture catch346 can hold the suture 342 with a friction fit or with a clamping forceand can have a suture lock that can be released after the distal anchor340 has been deployed/formed into a bulky knot.

The suture 342 (also referred to herein as “tether”) is formed into anelongated coiled configuration and is disposed within the outer tube 331at the distal end portion 332 of the delivery device 330. As describedabove for suture 242, two strands of the suture 342 extend from thedistal elongated coiled portion of the suture 342, extend through thelumen of the needle 341, through a passageway of the plunger 348 andexit the plunger and needle 341 at a proximal end portion of theplunger. The distal elongated coiled portion of the suture 342 will beformed into the distal anchor 340 (e.g., bulky knot) upon actuation ofthe delivery device 330 as described in more detail below. As discussedabove for distal anchors 140 and 240, the distal anchor 340 can be inthe form of one or more multi-turn coils of the suture 342 that can bechanged from the elongated coiled configuration during delivery to aknot configuration by approximating opposite ends of the coils towardseach other, to form one or more loops.

To deliver and form the distal anchor 340 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of332 of the delivery device 330 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 333contacts a proximal side of the mitral valve leaflet L as shown in FIG.14A. In this embodiment, with the delivery device 330 positioned againstthe mitral leaflet L, and with a proximal end portion of the suture 342(e.g., two suture strands of suture 342) secured to the suture catch346, the plunger (not shown) is actuated to move the needle hub 343, theneedle 341, the pusher 337 and pusher hub 339, and the coiled portion ofthe suture 332 (e.g., distal anchor 340) distally until the plungercontacts a stop member (not shown) within the handle 335, which limitsthe travel of the plunger in the distal direction. As the plunger isactuated, a distal piercing portion 347 of the needle 341 and in somecases, at least the first wrap of the coiled portion of the suture 332,punctures the leaflet L and forms an opening in the leaflet L (see,e.g., FIG. 14B). The distance the distal end portion of the needle 341extends within the left atrium on the distal side of the leaflet L isdetermined by the amount of travel allowed by the plunger. Thus, in thisembodiment, the delivery device 330 is configured to advance the distalend portion of the needle 341 a shorter distance, for example, between5-8 mm (about 0.2-0.3 inches) (e.g., about 6 mm (about 0.25 inches)), orless, distally beyond the distal end of the delivery device 330 (e.g.,beyond the end effector 333), compared to the embodiment of FIGS. 6-10in which the needle extends about 2.5 cm (about 1 inch). In otherembodiments, the needle can be extended outside the delivery device adistance of about 4-10 mm (about 0.15-0.4 inches). When the plungerreaches the stop member, the pusher 337 and pusher hub 339 are releasedfrom the plunger 348 and are advanced further distally to a distalposition within the handle 335 (see FIG. 14C) where the pusher hub 339(and pusher 337) can optionally lock into place. Details of how thepusher 337 and pusher hub 339 are moved within the lumen of the handle335 are described below with respect to delivery device 430.

As the pusher 337 is moved distally, a distal end of the pusher 337moves or pushes the distal coiled portion of the suture 342 (e.g.,distal anchor 340) over the distal end of the needle 341 and furtherwithin the left atrium of the heart on a distal side of the mitralleaflet (see FIG. 14C). In other words, the distal end of the pusher 337and the distal coiled portion of the suture 342 extends beyond thedistal end of the needle 341. For example, in some embodiments, at leasthalf a length of the distal coiled portion of the suture 342 extendsbeyond the distal end of the needle 341. In some embodiments, at leastthree quarters of the length of the distal coiled portion of the suture342 extends beyond the distal end of the needle 341. In otherembodiments, the entire length of the distal coiled portion of thesuture 342 extends beyond the distal end of the needle 341. To allow thedistal coiled portion of the suture 342 (e.g., distal anchor 340) toslide relative to the plunger, when the suture 342 is loaded within thedelivery device 330, there is slack in the suture 342 between the distalcoiled portion of the suture 342 and the suture lock within the suturecatch 346.

After the distal coiled portion of the suture 342 is moved to the distalside of the leaflet L, the plunger is then released such that theplunger moves proximally, which moves or pushes the needle 341 andsuture catch 346 proximally, pulling the suture 342 (e.g., suturestrands extending from the coiled portion of the suture) through thepusher 337 to form the bulky knot configuration (as shown in FIG. 14D)of the distal anchor 340 by approximating opposite ends of the coils ofthe elongated coil portion of the suture 342 towards each other, to formone or more loops. As shown in FIG. 14D, by pulling on the proximal endsof the suture 342, the coils are pulled against the distal end of thepusher 337 to form the knot. After the distal anchor 340 has formed aknot, the proximal end portions of the suture 342 can be released fromthe suture catch 346 and the delivery device 330 can be withdrawnproximally, leaving the distal anchor 340 disposed on the distal side ofthe leaflet L (as shown in FIG. 14E), and two lengths or strands of thesuture 332 extending out of the heart. In other words, with the suture342 released from the suture catch 346, the delivery device 330 can beslid over the suture 342 for removal.

As described above for previous embodiments, the lengths or strands ofthe suture 342 between the distal anchor 340 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 342 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. The result can thus be that one or more anchor-tetherapparatuses (e.g., anchor-tether apparatus 145) as described above areeach anchored on a distal side of a leaflet with a distal anchor andsecured to the apex of the heart with a proximal anchor via the tether342. Alternatively, if one or more anchor-tether apparatus is attachedto both mitral valve leaflets an anchor-tether apparatus attached toeach leaflet can be secured together in the heart by tying them togetherwith knots or by another suitable attachment member (not shown),creating an edge-to-edge repair to decrease the septal-lateral distanceof the mitral valve orifice. The two attached anchor-tether apparatuscan be left loose or tensioned to create a “facilitated” edge-to-edgerepair before being secured to an outer surface of the heart with aproximal anchor.

FIGS. 15A-22C and 23-27 illustrate another embodiment of a deliverydevice that can be used to deliver and form a bulky knot distal anchorto be disposed on a distal side of a mitral valve leaflet using a shortthrow deployment sequence. As shown in cross-section in FIGS. 15A and15B, a delivery device 430 includes a distal end portion 432, a proximalend portion 436 and a medial portion 434. The distal end portion 432 caninclude an end effector 433 (best shown in FIG. 15C) that can be placedin contact with a leaflet of a mitral valve as described above. The endeffector 433 can be coupled to a distal end portion of an outer tube 431(also shown in FIG. 15C) and a proximal end portion of the outer tube431 is coupled to a handle 435 at the proximal end portion 436. Anelongate pusher 437 is movably disposed within a lumen of the outer tube431 (see, e.g., FIG. 15C) and is coupled to a pusher hub 439 that ismovably disposed within the handle 435 and releasably coupled to aplunger 448. A needle 441 is movably disposed within a lumen of thepusher 437 (see, e.g., FIG. 17B) and is coupled to a needle hub 443 thatis also coupled to the plunger 448. The plunger 448 is used to actuateor move the needle 441 and the pusher 437 during deployment of a distalanchor 440 (see, e.g., FIGS. 19B and 20B) and is movably disposed atleast partially within the handle 435. For example, the handle 435defines a lumen in which the plunger 448 can be moved. During operation,the pusher 437 also moves within the lumen of the handle 435 asdescribed in more detail below. The delivery device 430 also includes alocking lever 449 that can be used to prevent the plunger 448 frommoving within the handle 435 during storage and prior to performing aprocedure to deploy the distal anchor.

A suture catch 446 (also referred to as “tether catch”) is also coupledto the plunger 448 at a proximal end of the delivery device 430 (bestshown in FIG. 15D). The suture catch 446 can be configured to releasablyhold or secure a suture 442 extending through the delivery device 430during delivery of the distal anchor as described above and as describedin more detail below. In some embodiments, the suture catch 446 can holdthe suture 442 with a friction fit or with a clamping force and can havea lock that can be released after the distal anchor 440 has beendeployed/formed into a bulky knot. The suture catch 446 includes an arm480 and contact members 481 (e.g., silicone O-rings) coupled to the arm480 (see, e.g., FIG. 12D). The arm 480 can be moved from a closedposition (as shown in FIGS. 15A, 15B, 16, 17A, 18A and 19A) in which thecontact members 481 engage the suture strands 442 within a slot 483 inthe plunger 448, to an open position (as shown in FIGS. 15D and 20A)thereby allowing the proximal end portions of the suture 442 to bereleased from the suture catch 446. The delivery device 430 can then bewithdrawn proximally, leaving the distal anchor 440 disposed on thedistal side of the leaflet L, and the two lengths of the suture 442extending out of the heart, as described with respect to previousembodiments. When in the closed position, the arm 480 and the contactmembers 481 pinch or otherwise secure the suture 442 to prevent orotherwise limit the suture 442 from moving relative to the device 430.When in the open position (e.g., after delivery of the distal anchor 440and during removal of the device 430 from the heart), the arm 480 andthe contact members 481 allow movement of the suture 442 relative to thedevice 430 such that the device 430 can be separated from the suture442, as described in more detail below.

A distal end portion of the suture 442 (also referred to herein as“tether”) is formed into an elongated coiled configuration and isdisposed within the outer tube 431 at the distal end portion 432 of thedelivery device 430. For example, the coils of the suture 442 can beprovided or shipped disposed around the needle 441 with the proximalmost coil abutting against the suture 442. As described above for thesuture 242 and the suture 342, two strands of the suture 442 extend fromthe distal elongated coiled portion of the suture 442, extend throughthe lumen of the needle 441, through a passageway of the plunger 448 andexit the plunger 448 at a proximal end portion of the plunger 448 (see,e.g., FIG. 15D). The distal elongated coiled portion of the suture 442will be formed into the distal anchor 440 (e.g., bulky knot) uponactuation of the delivery device 430 as described in more detail below.As discussed above for the distal anchors 140, 240 and 340, the distalanchor 440 (e.g., bulky knot) can be in the form of one or moremulti-turn coils of the suture 442 that can be changed from theelongated coiled configuration during delivery to a knot configurationby approximating opposite ends of the coils towards each other, to formone or more loops.

As shown in detail in FIGS. 22A-22C, the delivery device 430 alsoincludes a fluid transfer system 460. The fluid transfer system 460 isconfigured to facilitate flushing of a portion of the delivery device430 and/or to facilitate the removal of undesirable fluids during theprocedure. In some instances, for example, the fluid transfer system 460be used to flush air out of the delivery device 430 (e.g., air locatedbetween the pusher 437 and the outer tube 431). As another example, thefluid transfer system 460 can be used to limit or prevent blood fromundesirably flowing from a patient into the delivery device 430 during aprocedure. The fluid transfer system 460 includes a fluid pathway 461and a connection port 462 disposed external to the handle 435. As shownbest in cross-sectional view in FIG. 22C, the fluid pathway 461 is influid communication with the connection port 462 and a volume definedbetween the lumen of the outer tube 431 and an outer surface of thepusher 437. Further, as shown best in FIG. 22C, the fluid transfersystem 460 includes a fluid sealing member 465 (e.g., an O-ring)disposed about the pusher 437 and configured to fluidically isolate thefluid pathway 461 from a volume within the handle 435 proximal to thefluid transfer system 460. The fluid transfer system 460 also includesconnection port sealing member 463 (e.g., a cap, a plug, or the like)configured to be coupled to the connection port 462 to fluidicallyisolate the fluid pathway 461 from a volume external to the fluidtransfer system 460 and/or the delivery device 430. Optionally, theconnection port sealing member 463 can be retained and/or storedproximate to the connection port 462 via a leash member 464 (as shown inFIG. 22A).

To prepare the delivery device 430 for delivering and forming a distalanchor 440 within, for example, a left atrium of the heart to repair amitral valve, the locking lever 449 is released from its locked orengaged position (e.g., its position during storage of the deliverydevice 430) in which the plunger 448 is prevented from moving (e.g.,proximally and distally) within the handle 435 to its unlocked ordisengaged position in which the plunger 448 can be moved within thehandle, as described in further detail below.

To deliver and form the distal anchor 440 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of432 of the delivery device 430 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 433contacts a proximal side of the mitral valve leaflet L as shown inprogression in FIGS. 23 and 24. With the delivery device 430 positionedagainst the mitral leaflet L (see, e.g., FIG. 24), and with a proximalend portion of the suture 442 (e.g., two suture strands of the suture442) secured to the suture catch 446, the plunger 448 is actuated tomove the needle hub 443, the needle 441, the pusher 437 and pusher hub439, and the coiled portion of the suture 432 (e.g., the distal anchor440) distally until the plunger 448 contacts a stop member 421 withinthe handle 435 (see, e.g., FIG. 18A), which limits the travel of theplunger 448 in the distal direction. As the plunger 448 is actuated, adistal piercing portion 447 of the needle 441 punctures the leaflet Land forms an opening in the leaflet L (see, e.g., FIG. 17B). Because theneedle 441 is coupled to the plunger 448 and moves with the plunger 448,the distance the distal end portion of the needle 441 extends within theleft atrium on the distal side of the leaflet L (see, e.g., FIG. 17B) isdetermined by the amount of travel allowed by the plunger 448. Thus, inthis embodiment, the delivery device 430 is configured to advance thedistal end portion of the needle 441 a shorter distance, for example,between about 5-8 mm (about 0.2-0.3 inches) (e.g., about 6 mm (about0.25 inches)), or less, distally beyond the distal end of the deliverydevice 430 (e.g., beyond the end effector), compared to the embodimentof FIGS. 6-10 in which the needle extends about 2.5 cm (about 1 inch).In other embodiments, the needle can be extended outside the deliverydevice a distance of about 4-10 mm (about 0.15-0.4 inches). For example,in some embodiments, the needle extends until the distal tip of theneedle 441 and a first wrap or two of the coiled suture 442 extendthrough the leaflet. When the plunger 448 reaches the stop member, thepusher 437 and pusher hub 439 are released from the plunger 448 and areadvanced further distally to a distal position within the handle 435, asshown in progression in FIGS. 17A and 18A. Details of how the pusher 437and pusher hub 439 are moved within the lumen of the handle 435 andreleased from the plunger 448 are described below with respect to FIGS.18A-21.

As shown in FIGS. 17A and 18A, the pusher hub 439 is configured tocomplimentarily mate with an opening 492 defined by and located at adistal end portion of the plunger 448. In use, prior to deployment, aproximal end portion of the pusher hub 439 is disposed within theopening 492 defined by the plunger 448 (see, e.g., FIGS. 16 and 17A). Inthis position, a pair of tabs 485 of a spring member 486 coupled to thepusher hub 439 are disposed within slots 487 defined by the plunger 448.For example, the spring member 486 can have a biased configuration inwhich the tabs 485 are disposed in an open position, and when the pusherhub 439 is coupled to the plunger 448 the tabs 485 are compressed by theinner walls of the handle 435, which define a first portion FP of apassageway within the handle 435. As the pusher hub 439 is moveddistally, the spring member 486 will slide into a second portion SP ofthe passageway of the handle 435 which has a larger size, allowing thetabs 485 to move to their biased open configuration and disengaging thetabs 485 from the slots 487 of the plunger 448 (see, e.g., theprogression in FIGS. 17A and 18A).

When the plunger 448 is actuated (e.g., moved distally within the handle435), the pusher hub 439 will move distally with the plunger 448 untilthe plunger 448 reaches the stop member 421 (see, e.g., FIG. 18A), atwhich point the pusher hub 439 is moved into the second portion SP ofthe passageway of the handle 435 as described above, allowing the tabs485 on the spring member 486 to disengage or release the pusher hub 439from the plunger 448. Upon release from the plunger 448, the pusher 437and the pusher hub 439 are advanced further distally to a distalposition within the handle 435 as shown in FIG. 18A, in response to aforce provided by a biasing member 490 (e.g., a compression spring)disposed within a lumen of the plunger 448. The biasing member 490 iscoupled to and disposed between the pusher hub 439 and the needle hub443, as shown in FIG. 21. In this manner, with use of the biasing member490, a desirable and repeatable force can be applied to the pusher 437and the pusher hub 439, resulting in a desirable and repeatable deliveryof the distal anchor 440.

Prior to disengagement of the pusher 437 and the pusher hub 439 from theplunger 448 (e.g., prior to use of the delivery device 430 or during useas the distal piercing portion 447 of the needle 441 punctures theleaflet L and forms an opening in the leaflet L), the biasing member 490is in a compressed configuration (not shown) and the pusher 437 and thepusher hub 439 are in their ready state (see, e.g., FIGS. 16 and 17A),in which a portion of the pusher hub 439 is disposed within the opening492 of the plunger 448 as described above. To releasably retain thebiasing member 490 in the compressed configuration and the pusher 437and pusher hub 439 in their ready state, the pair of tabs 485 of thespring member 486 are disposed within the slots 487 of the plunger 448and the plunger 448 is disposed in the first portion of the passagewaywithin the handle 435.

As shown in FIG. 21, a guide member 455 is disposed within a lumendefined by the biasing member 490 and coupled to the pusher hub 439.During distal advancement of the pusher 437 and the pusher hub 439within the handle 435, and transition of the biasing member 490 betweenits unbiased compressed configuration and is biased uncompressedconfiguration, the guide member 455 can facilitate desirable alignmentwithin the handle 435 (e.g., alignment within the handle 435 of thepusher 437, the pusher hub 439, and the plunger 448). In addition, theguide member 455 can provide structural support to the biasing member490 (e.g., during transition of the biasing member 490 between itsbiased and unbiased configurations).

Although the lumen of the handle 435 is shown in this embodiment asbeing rectangular, in some embodiments, the lumen of the handle can haveany suitable shape (e.g., a circular or semi-circular shape). In suchembodiments, the components that cooperatively function within thehandle 435 (e.g., the pusher 437, the pusher hub 439, the plunger 448),as described above with respect the delivery device 430, can be suitablysized and/or shaped to cooperatively function with any shape and/or sizeselected for a particular handle and lumen defined therein.

In use, as the plunger 448 is actuated to move the pusher 437 and thepusher hub 439 distally within the handle 435, the plunger 448 willreach the stop member 421 at which point in time the spring member 486will slide into the second portion SP of the passageway of the handle435 which has the larger size, allowing the tabs 485 to move to theirbiased open configuration and disengaging the tabs 485 from the slots487 of the plunger 448. In this manner, the biasing member 490 will bereleased from its compressed configuration and transition towards abiased uncompressed configuration thereby resulting in travel of thepusher 437 and the pusher hub 439 distally within the handle 435. As thepusher 437 is moved distally, a distal end of the pusher 437 moves orpushes the distal coiled portion of the suture 442 (e.g., distal anchor440) over the distal end of the needle 441 and further within the leftatrium of the heart on a distal side of the mitral leaflet (see, e.g.,FIGS. 18A, 18B and 25), such that the coiled portion of the sutureextends distally beyond a distal end of the needle 441. For example, insome embodiments, at least half a length of the distal coiled portion ofthe suture 442 extends beyond the distal end of the needle 441. In someembodiments, at least three quarters of the length of the distal coiledportion of the suture 442 extends beyond the distal end of the needle441. In other embodiments, the entire coiled portion of the suture 442extends beyond the distal end of the needle 441. To allow the distalcoiled portion of the suture 442 (e.g., distal anchor 440) to sliderelative to the plunger 448, when the suture 442 is loaded within thedelivery device 430, there is slack SL (a portion of which is shown inFIG. 15D) in the suture 442 between the distal coiled portion of thesuture 442 and the suture lock within the suture catch 446.

After the distal coiled portion of the suture 442 is moved to the distalside of the leaflet L, the plunger 448 is released to allow the plunger448 to move proximally, which moves or pushes the needle 441 and suturecatch 446 proximally, as shown in FIG. 19A. For example, in someembodiments, the plunger 448 can be actuated by the user manuallypushing the plunger distally within the handle 435 with for example athumb or finger. To release the plunger 448, the user can release histhumb which allows the plunger 448 to be moved back proximally. Forexample, in some embodiments, when the user releases his thumb from theplunger 448, a biasing member (e.g., a spring) (not shown) can push theplunger 448 back in the proximal direction. When the suture catch 446 ismoved proximally, this in turn pulls the suture 442 (e.g., suturestrands extending from the coiled portion of the suture) proximally toform the bulky knot configuration of the distal anchor 440 against thedistal end of the pusher 437 (see, e.g., FIGS. 18B, 19B, 25 and 26). Forexample, as described above, the bulky knot is formed by approximatingopposite ends of the coils of the elongated coil portion of the suture442 towards each other, to form one or more loops, as shown in FIG. 16B.After the distal anchor 440 has formed a knot, the proximal end portionsof the suture 442 can be released from the suture catch 446. Thedelivery device 430 can then be withdrawn proximally, leaving the distalanchor 440 disposed on the distal side of the leaflet L, as shown inFIGS. 20A and 20B, and two lengths or strands of the suture 432extending from the proximal side of the leaflet L (see, e.g., FIG. 27)and out of the heart. In other words, with the suture 442 released fromthe suture catch 446 the delivery device 430 can be slid over the suture442 for removal.

As described above for previous embodiments, the lengths or strands ofthe suture 442 between the distal anchor 440 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 442 can then be secured to an outer surfaceof the heart at, for example, the apex, with a proximal anchor (notshown). The proximal anchor can be, for example, a pledget, one or moreknots, or other suitable anchoring device. As previously described, theabove procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. The result can thus be that one or more anchor-tetherapparatuses (e.g., anchor-tether apparatus 145) as described above areeach anchored on a distal side of a leaflet with a distal anchor andsecured to the apex of the heart with a proximal anchor via the tether442. Alternatively, if one or more anchor-tether apparatuses is attachedto both mitral valve leaflets, an anchor-tether apparatus attached toeach leaflet can be secured together in the heart by tying them togetherwith knots or by another suitable attachment member, creating anedge-to-edge repair to decrease the septal-lateral distance of themitral valve orifice. The two attached anchor-tether apparatuses can beleft loose or tensioned to create a “facilitated” edge-to-edge repairbefore being secured to an outer surface of the heart with a proximalanchor. As shown in FIG. 27, with the anchor-tether apparatus secured tothe mitral valve leaflet L, when closed, the free margins or edges ofthe leaflets come together and form a tight junction, the arc of whichis known as the line, plane or area of coaptation AC as previouslydescribed.

FIGS. 14A-14E described above illustrate one example method and devicefor deploying a bulky knot distal anchor using a delivery device thatutilizes a short throw deployment sequence configured to insert thedistal end portion and piercing member of the needle a shorter distanceinto the left atrium than as shown and described above for theembodiment of FIGS. 6-10. As shown and described with respect to FIGS.14A-14E, the distal end portion of the needle is used to puncture theleaflet tissue and form an opening in the leaflet tissue, but does notextend as far into the left atrium. In another embodiment, a bulky knotdistal anchor can be deployed/formed using a delivery device thatutilizes a full forward short throw deployment sequence. The fullforward short throw deployment sequence is similar to the short throwdeployment sequence of FIGS. 14A-14E, but causes the bulky knot distalanchor to be deployed/formed by moving the pusher distally relative tothe needle rather than pulling on the proximal ends of the suture topull the coils against the distal end of the pusher. FIGS. 28A-28E areschematic illustrations of an embodiment of a delivery device fordelivering and deploying a distal anchor and configured to provide sucha full forward short throw deployment sequence.

As shown in FIGS. 28A-28E, a delivery device 530 includes a distal endportion 532, a proximal end portion 536 and a medial portion 534. Thedistal end portion 532 includes an end effector 533 that can be placedin contact with a leaflet L of a mitral valve as described above withrespect to FIGS. 14A-14E. The end effector 533 is coupled to a distalend portion of an outer tube 531 and a proximal end portion of the outertube 531 is coupled to a handle 535 at the proximal end portion 536 ofthe delivery device 530. The end effector 533 can distribute the forceof the outer tube 531 over a larger area to prevent/eliminate puncturingof the leaflet with the delivery device 530 during deployment. In someembodiments, the end effector 533 can include a balloon (not shown). Anelongate pusher 537 is movably disposed within a lumen of the outer tube531 and is coupled to a pusher hub 539 that is movably disposed withinthe handle 535 and releasably coupled to a plunger (not shown). Forexample, the plunger can be constructed the same as or similar to theplunger 448 described above and function in a similar manner. A needle541 (see FIGS. 28C-28E) is movably disposed within a lumen of the pusher537 and is coupled to a needle hub 543 that is also releasably coupledto the plunger (not shown). The plunger is used to actuate or move theneedle 541 and the pusher 537 during deployment of a distal anchor 540and can be movably disposed at least partially within the handle 535.For example, the handle 535 defines a lumen in which the plunger can bemoved. During operation, the pusher 537 also moves within the lumen ofthe handle 535 as described in more detail below. The delivery device530 can also include a locking lever (not shown) that can be used toprevent the plunger from moving within the handle 535 during storage andprior to performing a procedure to deploy the distal anchor. Forexample, the locking lever can be similar to or the same as the lockinglever 449 described above.

A suture catch 546 (also referred to as “tether catch”) can be coupledto the plunger at a proximal end of the delivery device 530. The suturecatch 546 is configured to releasably hold or secure a suture 542extending through the delivery device 530 during delivery of the distalanchor 540 as described above for previous embodiments. In someembodiments, the suture catch 546 can hold the suture 542 with afriction fit or with a clamping force and can have a lock that can bereleased after the distal anchor 540 has been deployed/formed into abulky knot.

As described above for previous embodiments, the suture 542 (alsoreferred to herein as “tether”) can be formed into an elongated coiledconfiguration and is disposed within the outer tube 531 at the distalend portion 532 of the delivery device 530. As described above, forexample, for suture 242, two strands of the suture 542 can extend fromthe distal elongated coiled portion of the suture 542, extend throughthe lumen of the needle 541, through a passageway of the plunger andexit the plunger and needle 541 at a proximal end portion of theplunger. The distal elongated coiled portion of the suture 542 will beformed into the distal anchor 540 (e.g., bulky knot) upon actuation ofthe delivery device 530 as described in more detail below. As discussedabove for previous embodiments, the distal anchor 540 can be in the formof one or more multi-turn coils of the suture 542 that can be changedfrom the elongated coiled configuration during delivery to a knotconfiguration by approximating opposite ends of the coils towards eachother, to form one or more loops.

To deliver and form the distal anchor 540 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of532 of the delivery device 530 can be inserted through an apex portionor region of the heart and into the left ventricle until the endeffector 533 contacts a proximal side of the mitral valve leaflet L asshown in FIG. 28A. In this embodiment, with the delivery device 530positioned against only the ventricular side of the mitral leaflet L,without contacting the atrial side of that leaflet, and with a proximalend portion of the suture 542 (e.g., two suture strands of suture 542)secured to the suture catch 546, the plunger (not shown) can be actuated(e.g., moved or pushed in a distal direction relative to the handle535). The actuation of the plunger moves the needle hub 543, the needle541, the pusher 537 and pusher hub 539, the suture catch 546, and thecoiled portion of the suture 542 (e.g., distal anchor 540) distallyuntil the needle hub 543 (and needle 541) and the suture catch 546 reacha preset location within the handle where the needle hub 543, needle541, and suture catch 546 are disengaged from the plunger and theirtravel in the distal direction is stopped. The pusher 537, the pusherhub 539, and the coiled portion of the suture 542 continue to be moveddistally by the plunger.

In some embodiments, for example, a delivery device can include arelease mechanism configured to disengage the needle hub, the needle,and the suture catch from the plunger such that the plunger can continueto advance distally and move the pusher, the pusher hub, and the coiledportion of the suture distally. In some embodiments, the releasemechanism can be configured for automatic disengagement, while in otherembodiments, the mechanism can be configured to be actuated by theoperator. In some embodiments, the delivery device can also include oneor more stop members within the handle that can engage or contact theneedle hub (and suture catch) to limit or stop the travel of the needle(and suture catch) in the distal direction.

As the plunger is actuated, and prior to the needle 541 being disengagedfrom the plunger, a distal piercing portion 547 of the needle 541, andin some cases, at least the first wrap of the coiled portion of thesuture 542, punctures the leaflet L and forms an opening in the leafletL (see, e.g., FIG. 28B). The distance the distal piercing portion 547 ofthe needle 541 extends within the left atrium on the distal side of theleaflet L can be determined, for example, by the preset allowed amountof travel of the needle 541 described above (e.g., in some embodiments,the amount of travel can be determined at least in part by a stop memberwithin the handle and/or a mechanism to release the needle hub from theplunger). In some embodiments, the delivery device 530 can be configuredto advance the distal piercing portion 547 of the needle 541 a shorterdistance into the left atrium than as shown and described above for theembodiment of FIGS. 6-10. For example, in some embodiments, the needlehub 543 can travel about 6 mm (about 0.25 inches) during actuation ofthe plunger. In some embodiments, the needle 541 can be extended outsideof the distal end of the delivery device (e.g., beyond the end effector)half the distance that is shown and described for the embodiment ofFIGS. 6-10. In some embodiments, the needle 541 can be extended outsidethe delivery device a distance of about 5-8 mm (about 0.2-0.3 inches)(e.g., about 6 mm (about 0.25 inches)).

As described above, when the needle hub 543, the needle 541 and suturecatch 546 disengage from the plunger, the plunger continues to be moveddistally, which in turn moves the pusher 537, the pusher hub 539, andthe coiled portion of the suture 542 (e.g., distal anchor 540) furtherdistally. For example, in some embodiments, the pusher 537 can be moveddistally about an additional 6-17 mm (0.25-0.65 inches) (e.g., about 10mm (about 0.4 inches)) during actuation of the plunger. Thus, in someembodiments, the total travel of the pusher can be, for example, about10-23 mm (about 0.4-0.9 inches) (e.g., about 17 mm (about 0.65 inches)).Similarly, in some embodiments, the pusher can be extended through theproximal side of the heart valve leaflet a distance of about 10-23 mm(about 0.4-0.9 inches) (e.g., about 17 mm (about 0.65 inches)) from theproximal side of the heart valve leaflet. As yet a further example ofthe short throw deployment sequence, the pusher can be moved through theopening of the leaflet from the proximal side of the leaflet and canextend a distance of 6-17 mm (0.25-0.65 inches) (e.g., about 10 mm(about 0.4 inches)) from and distal to the distal side of the leaflet.

As the pusher 537 is moved distally, with the suture catch 546, theneedle 541 and the needle hub 543 in fixed positions relative to thepusher 537 (e.g., the suture catch 546, the needle 541, and the needlehub 543 are disengaged from the plunger), a distal end of the pusher 537moves or pushes the distal coiled portion of the suture 542 (e.g.,distal anchor 540) over the distal end of the needle 541 and furtherwithin the left atrium of the heart on a distal side of the mitralleaflet (see FIG. 28C). In this manner, the distal end of the pusher 537pushes the coiled portion of the suture 542 (e.g., distal anchor 540)distally off the needle 541. To allow the distal coiled portion of thesuture 542 (e.g., distal anchor 540) to slide relative to and eventuallyoff the needle 541, when the suture 542 is loaded within the deliverydevice 530, there can be slack formed in the suture 542 between thedistal coiled portion of the suture 542 and the suture lock within thesuture catch 546. As shown in FIG. 28D, as the pusher 537 continues tomove distally relative to the needle 541, the coiled portion of thesuture 542 forms the bulky knot configuration of the distal anchor 540by approximating opposite ends of the coils of the elongated coilportion of the suture 542 towards each other, to form one or more loops(two loops are shown in FIG. 28D). For example, with the opposite endportions of the suture 542 fixed and secured within the suture catch546, as the pusher 537 moves distally, the coils are forced against thedistal end of the pusher 537 to form the knot.

In use, in some instances, the plunger can be actuated to move theneedle hub 543 as described above, while maintaining the entire distalportion of the delivery device 530 on the ventricular side of theleaflet L. In this manner, in such instances, the distal anchor 540 canbe delivered to and/or deployed at the distal side of the leafletwithout some form of mechanical fixation to and/or capturing of theleaflet L prior to piercing the leaflet with the needle 541. Unlikeconventional open-heart surgery, where the heart is stopped and thesurgeon can see and manipulate stationary leaflets, in a minimallyinvasive procedure (e.g., with a beating heart), the operator cannot seethe leaflet directly, and instead, must rely on an ultrasonic or otherimage of the moving leaflet and the device. In practice, this image isoften displayed on a display device for the operator after a slight timedelay. As such, immobilizing the otherwise moving leaflet can bechallenging and has the potential to further damage the leaflet. Beingable to deliver and deploy a distal anchor without having tomechanically fix to and/or capture the otherwise moving leaflet (e.g.,prior to piercing the leaflet to form an opening through with the distalanchor is delivered) eliminates or at least limits the challengesdiscussed above. Additionally, being able to deliver and deploy thedistal anchor using a single device (e.g., without using a separatedevice to immobilize and/or capture the leaflet) further reduceschallenges and risks associated with such procedures.

After the distal anchor 540 has formed a knot, the proximal end portionsof the suture 542 can be released from the suture catch 546 and thedelivery device 530 can be withdrawn proximally, leaving the distalanchor 540 disposed on the distal side of the leaflet L (as shown inFIG. 28E), and two lengths or strands of the suture 532 extending out ofthe heart. In other words, with the suture 542 released from the suturecatch 546 the delivery device 530 can be slid proximally over the suture542 for removal. Forming/deploying the bulky knot using the full forwardshort throw deployment sequence described above can simplify theprocedure for an operator of the delivery device 530 because theoperator can deploy the bulky knot by applying a single distal force tothe plunger. Further, after the plunger is actuated and the bulky knotis formed, the operator can remove the delivery device 530 from thepatient by withdrawing the delivery device 530 proximally without, forexample, having to wait for the plunger to move proximally to form thebulky knot, leaving the bulky knot disposed on the distal side of theleaflet L. Simplifying a procedure in this manner such that an operatorcan implant an artificial chordae by applying, for example, a push forceto the plunger, and then remove the entire delivery device bywithdrawing the delivery device proximally, promotes a repeatable andpredictable procedure.

As described above for previous embodiments, the lengths or strands ofthe suture 542 between the distal anchor 540 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 542 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. The result can thus be that one or more anchor-tetherapparatuses (e.g., anchor-tether apparatus 145) as described above areeach anchored on a distal side of a leaflet with a distal anchor 540 andsecured to the apex of the heart with a proximal anchor via the tether542. Alternatively, if one or more anchor-tether apparatuses is attachedto both mitral valve leaflets, an anchor-tether apparatus attached toeach leaflet can be secured together in the heart by tying them togetherwith knots or by another suitable attachment member (not shown),creating an edge-to-edge repair to decrease the septal-lateral distanceof the mitral valve orifice. The two attached anchor-tether apparatusescan be left loose or tensioned to create a “facilitated” edge-to-edgerepair before being secured to an outer surface of the heart with aproximal anchor.

In some embodiments, the suture catch can be coupled in a fixed positionrelative to the handle of the delivery device, rather than being coupledto the plunger. Thus, the proximal portion of the suture coupled to thesuture catch is in a fixed position relative to the handle. In suchembodiments, there can be sufficient slack formed in the suture betweenthe distal coiled portion of the suture and the suture lock within thesuture catch to allow the distal coiled portion of the suture (e.g.,distal anchor) to slide relative to and eventually off the needle, whenthe plunger is advanced distally. Alternatively or in addition to,providing slack in the suture, a spring can be disposed in the handleand coupled to the suture between the distal coiled portion of thesuture (e.g., the distal anchor) and the suture lock, which can expandlongitudinally as the plunger is moved distally.

FIGS. 28A-28E described above illustrate one example method and devicefor deploying a bulky knot distal anchor using a delivery device thatutilizes a full forward short throw deployment sequence configured toinsert the distal end portion and piercing member of the needle ashorter distance into the left atrium than as shown and described abovefor the embodiment of FIGS. 6-10. Such a full forward short throwdelivery sequence is configured to cause the bulky knot distal anchor tobe deployed/formed by moving the pusher distally relative to the needlerather than pulling on the proximal ends of the suture to pull the coilsagainst the distal end of the pusher. In another embodiment, a bulkyknot distal anchor can be deployed/formed using a delivery device thatutilizes an independent full forward short throw deployment sequence.The independent full forward short throw deployment sequence is similarto the full forward short throw deployment sequence of FIGS. 28A-28E,except the pusher and the needle are configured to move independent ofeach other (e.g., the pusher and the needle can each be coupled to adifferent component of the actuator and/or be actuated separately). Forexample, the pusher and needle can be moved within the handle and theouter tube independently of each other and during varying time periodsin response to separate force-providing mechanisms. FIGS. 29A-29E areschematic illustrations of an embodiment of a delivery device fordelivering and deploying a distal anchor using an independent fullforward short throw deployment sequence.

As shown in FIGS. 29A-29E, a delivery device 630 includes a distal endportion 632, a proximal end portion 636 and a medial portion 634. Thedistal end portion 632 includes an end effector 633 that can be placedin contact with a leaflet L of a mitral valve as described above withrespect to previous embodiments. The end effector 633 is coupled to adistal end portion of an outer tube 631 and a proximal end portion ofthe outer tube 631 is coupled to a handle 635 at the proximal endportion 636 of the delivery device 630. The end effector 633 candistribute the force of the outer tube 631 over a larger area toprevent/eliminate puncturing of the leaflet with the delivery device 630during deployment. In some embodiments, the end effector 633 can includea balloon (not shown). An elongate pusher 637 is movably disposed withina lumen of the outer tube 631 and is coupled to a pusher hub 639 that ismovably disposed within the handle 635 and coupled to an actuator (notshown). The actuator can be used to actuate or move the pusher hub 639and the pusher 637 during deployment of a distal anchor 640 and can bemovably disposed at least partially within the handle. A needle 641 (seeFIG. 29B) is movably disposed within a lumen of the pusher 637 and iscoupled to a needle hub 643 that is coupled to an actuator (not shown)and/or energy storage member (not shown). The actuator can be used toactuate or move the needle hub 643 and the needle 641 (both independentof the pusher hub and the pusher) during deployment of the distal anchor640 and can be movably disposed at least partially within the handle635. For example, the handle 635 can define a lumen in which theactuator or a portion of the actuator can be actuated and/or moved. Thedelivery device 630 can also include a locking lever (not shown) thatcan be used to prevent the actuator(s) and/or one or more of itsconstituent components from actuating and/or moving within or relativeto the handle 635 during, for example, storage and/or prior toperforming a procedure to deploy the distal anchor. For example, thelocking lever can be similar to or the same as the locking lever 449described above.

A suture catch 646 (also referred to as “tether catch”) can be coupledto a proximal end of the delivery device 630. The suture catch 646 isconfigured to releasably hold or secure a suture 642 extending throughthe delivery device 630 during delivery of the distal anchor 640 asdescribed above for previous embodiments. In some embodiments, thesuture catch 646 can hold the suture 642 with a friction fit or with aclamping force and can have a lock that can be released after the distalanchor 640 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture 642 (alsoreferred to herein as “tether”) can be formed into an elongated coiledconfiguration and is disposed within the outer tube 631 at the distalend portion 632 of the delivery device 630. As described above, forexample, for suture 242, two strands of the suture 642 can extend fromthe distal elongated coiled portion of the suture 642, and extendthrough the lumen of the needle 641. The distal elongated coiled portionof the suture 642 will be formed into the distal anchor 640 (e.g., bulkyknot) upon actuation of the delivery device 630 as described in moredetail below. As discussed above for previous embodiments, the distalanchor 640 can be in the form of one or more multi-turn coils of thesuture 642 that can be changed from the elongated coiled configurationduring delivery to a knot configuration by approximating opposite endsof the coils towards each other, to form one or more loops.

To deliver and form the distal anchor 640 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of632 of the delivery device 630 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 633contacts a proximal side of the mitral valve leaflet L as shown in FIG.29A. In this embodiment, with the delivery device 630 positioned againstonly the ventricular side of the mitral leaflet L, and with a proximalend portion of the suture 642 (e.g., two suture strands of suture 642)secured to the suture catch 646, the actuator can be actuated and/ormoved to move both the needle hub 643 and the needle 641 distallyrelative to the handle 635, the pusher hub 639 and the pusher 637. Theneedle hub 643 and the needle 641 (with the coiled portion of the suture642 coupled thereto) are moved distally until the needle hub 643 andneedle 641 reach a preset location within the handle 635, at which pointtheir travel in the distal direction is stopped.

In some embodiments, the delivery device can also include one or morestop members within the handle that can engage or contact the needle hubto limit or stop the travel of the needle in the distal direction.

As the needle 641 is advanced distally within the handle 635, a distalpiercing portion (not shown) of the needle 641, and in some cases, atleast the first wrap of the coiled portion of the suture 642, puncturesthe leaflet L and forms an opening in the leaflet L (see, e.g., FIG.29B). The distance the distal piercing portion of the needle 641 extendswithin the left atrium on the distal side of the leaflet L can bedetermined, for example, by the preset allowed amount of travel of theneedle 641 described above (e.g., in some embodiments, the amount oftravel can be determined at least in part by a stop member within thehandle and/or a mechanism disposed within the handle 635). In someembodiments, the delivery device 630 can be configured to advance thedistal piercing portion of the needle 641 a shorter distance into theleft atrium than as shown and described above for the embodiment ofFIGS. 6-10. For example, in some embodiments, the needle hub 643 cantravel about 6 mm (about 0.25 inches). In some embodiments, the needlecan be extended outside of the distal end of the delivery device (e.g.,beyond the end effector) half the distance that is shown and describedfor the embodiment of FIGS. 6-10. In some embodiments, the needle can beextended outside the delivery device a distance of about 5-8 mm (about0.2-0.3 inches) (e.g., about 6 mm (about 0.25 inches)).

With a portion of the needle 641 disposed within the left atrium, anactuator (not shown) (e.g. a plunger or other type of actuatormechanism) can be actuated and/or moved to cause the pusher hub 639 andin turn the pusher 637 to move distally within the handle 635 andrelative to the needle 641 and needle hub 643, as shown by FIG. 29C. Inthis manner, the pusher 637 can urge the coiled portion of the suture642 (e.g., the distal anchor 640) further distally relative to theneedle 641, as described in further detail herein. For example, in someembodiments, with the end effector 633 in contact with the proximal sideof the mitral valve leaflet L, the pusher 637 can be moved distallyabout 17 mm (about 0.65 inches).

As the pusher 637 is moved distally, with the suture catch 646, theneedle 641 and the needle hub 643 in fixed positions relative to thepusher 637, a distal end of the pusher 637 moves or pushes the distalcoiled portion of the suture 642 (e.g., distal anchor 640) over thedistal end of the needle 641 and further within the left atrium of theheart on a distal side of the mitral leaflet (see FIG. 29C). In thismanner, the distal end of the pusher 637 pushes the coiled portion ofthe suture 642 (e.g., distal anchor 640) distally off the needle 641. Toallow the distal coiled portion of the suture 642 (e.g., distal anchor640) to slide relative to and eventually off the needle 641, when thesuture 642 is loaded within the delivery device 630, there can be slackformed in the suture 642 between the distal coiled portion of the suture642 and the suture lock within the suture catch 646. As shown in FIG.29D, as the pusher 637 continues to move distally relative to the needle641, the coiled portion of the suture 642 forms the bulky knotconfiguration of the distal anchor 640 by approximating opposite ends ofthe coils of the elongated coil portion of the suture 642 towards eachother, to form one or more loops (two loops are shown in FIG. 29D). Forexample, with the opposite end portions of the suture 642 fixed andsecured within the suture catch 646, as the pusher 637 moves distally,the coils are forced against the distal end of the pusher 637 to formthe knot.

After the distal anchor 640 has formed a knot, the proximal end portionsof the suture 642 can be released from the suture catch 646 and thedelivery device 630 can be withdrawn proximally, leaving the distalanchor 640 disposed on the distal side of the leaflet L (as shown inFIG. 29E), and two lengths or strands of the suture 632 extending out ofthe heart. In other words, with the suture 642 released from the suturecatch 646, the delivery device 630 can be slid proximally over thesuture 642 for removal. In some embodiments, after the distal anchor 640has formed a knot, and the proximal end portions of the suture 642 arereleased from the suture catch 646, the needle 641 and/or the pusher 637can be withdrawn proximally within and relative to the outer tube 631.In some instances, the needle 641 and/or the pusher 637 are withdrawnproximally into the outer tube 631 before the delivery device 630 iswithdrawn proximally, while in other instances, the needle 641 and/orthe pusher 637 are withdrawn proximally into the outer tube 631 as thedelivery device 630 is withdrawn proximally.

As described above for previous embodiments, the lengths or strands ofthe suture 642 between the distal anchor 640 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 642 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. Thus, as a result, one or more anchor-tether apparatuses (e.g.,anchor-tether apparatus 145) can be anchored on a distal side of aleaflet with a distal anchor 640 and secured to the apex of the heartwith a proximal anchor via the tether 642. Alternatively, if one or moreanchor-tether apparatuses is attached to both mitral valve leaflets, ananchor-tether apparatus attached to each leaflet can be secured togetherin the heart by tying them together with knots or by another suitableattachment member (not shown), creating an edge-to-edge repair todecrease the septal-lateral distance of the mitral valve orifice. Thetwo attached anchor-tether apparatuses can be left loose or tensioned tocreate a “facilitated” edge-to-edge repair before being secured to anouter surface of the heart with a proximal anchor.

In some embodiments, alternatively or in addition to providing slack inthe suture, a spring can be disposed in the handle and coupled to thesuture between the distal coiled portion of the suture (e.g., the distalanchor) and the suture lock, which can expand longitudinally as thedistal anchor is moved distally relative to the handle as describedabove.

In another embodiment, a bulky knot distal anchor can be deployed/formedusing a delivery device that utilizes an independent short throwdeployment sequence. The independent short throw deployment sequence issimilar to the independent full forward short throw deployment sequenceof FIGS. 29A-29E, except the bulky knot distal anchor is deployed/formedby pulling on the proximal ends of the suture to pull the coils againstthe distal end of the pusher rather than moving the pusher distallyrelative to the needle. Similar to the embodiment of FIGS. 29A-29E, forexample, the pusher and needle can be moved within the outer tubeindependently of each other and during varying time periods in responseto separate force-providing mechanisms and/or separate energy storagemembers. Further, similar to the embodiment of FIGS. 14A-14E, the needlecan be moved proximally within and relative to the handle, pulling thesuture (e.g., suture strands extending from the coiled portion of thesuture) proximally through the pusher to form the bulky knotconfiguration of the distal anchor. FIGS. 30A-30E are schematicillustrations of an embodiment of a delivery device for delivering anddeploying a distal anchor and configured to provide such an independentshort throw deployment sequence.

As shown in FIGS. 30A-30E, a delivery device 730 includes a distal endportion 732, a proximal end portion 736 and a medial portion 734. Thedistal end portion 732 includes an end effector 733 that can be placedin contact with a leaflet L of a mitral valve as described above withrespect to previous embodiments. The end effector 733 is coupled to adistal end portion of an outer tube 731 and a proximal end portion ofthe outer tube 731 is coupled to a handle 735 at the proximal endportion 736 of the delivery device 730. The end effector 733 candistribute the force of the outer tube 731 over a larger area toprevent/eliminate puncturing of the leaflet with the delivery device 730during deployment. In some embodiments, the end effector 733 can includea balloon (not shown). An elongate pusher 737 is movably disposed withina lumen of the outer tube 731 and is coupled to a pusher hub 739 that ismovably disposed within the handle 735 and coupled to an actuator (notshown) and/or energy storage member (not shown). The actuator and/orenergy storage member can be used to actuate or move the pusher hub 739and the pusher 737 during deployment of a distal anchor 740 and can bemovably disposed at least partially within the handle. A needle 741 (seeFIG. 30B) is movably disposed within a lumen of the pusher 737 and iscoupled to a needle hub 743 that is coupled to an actuator (not shown).The actuator can be used to actuate or move the needle hub 743 and theneedle 741 (both independent of the pusher hub and the pusher) duringdeployment of the distal anchor 740 and can be movably disposed at leastpartially within the handle 735. For example, the handle 735 defines alumen in which the actuator or a portion of the actuator can be actuatedand/or moved. The delivery device 730 can also include a locking lever(not shown) that can be used to prevent the actuator and/or one or moreof its constituent components from actuating and/or moving within orrelative to the handle 735 during storage and prior to performing aprocedure or a particular portion thereof to deploy the distal anchor.For example, the locking lever can be similar to or the same as thelocking lever 449 described above.

A suture catch 746 (also referred to as “tether catch”) can be coupledto a proximal end of the delivery device 730. The suture catch 746 isconfigured to releasably hold or secure a suture 742 extending throughthe delivery device 730 during delivery of the distal anchor 740 asdescribed above for previous embodiments. In some embodiments, thesuture catch 746 can hold the suture 742 with a friction fit or with aclamping force and can have a lock that can be released after the distalanchor 740 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture 742 (alsoreferred to herein as “tether”) can be formed into an elongated coiledconfiguration and is disposed within the outer tube 731 at the distalend portion 732 of the delivery device 730. As described above, forexample, for suture 242, two strands of the suture 742 can extend fromthe distal elongated coiled portion of the suture 742, and extendthrough the lumen of the needle 741. The distal elongated coiled portionof the suture 742 will be formed into the distal anchor 740 (e.g., bulkyknot) upon actuation of the delivery device 730 as described in moredetail below. As discussed above for previous embodiments, the distalanchor 740 can be in the form of one or more multi-turn coils of thesuture 742 that can be changed from the elongated coiled configurationduring delivery to a knot configuration by approximating opposite endsof the coils towards each other, to form one or more loops.

To deliver and form the distal anchor 740 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of732 of the delivery device 730 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 733contacts a proximal side of the mitral valve leaflet L as shown in FIG.30A. In this embodiment, with the delivery device 730 positioned againstonly the ventricular side of the mitral leaflet L, and with a proximalend portion of the suture 742 (e.g., two suture strands of suture 742)secured to the suture catch 746, the actuator and/or energy storagemember can be actuated and/or moved to move both the needle hub 743 andthe needle 741 distally relative to the handle 735, the pusher hub 739and the pusher 737. The needle hub 743 and the needle 741 (with thecoiled portion of the suture 742 coupled thereto) are moved distallyuntil the needle hub 743 and needle 741 reach a preset location withinthe handle 735, at which point their travel in the distal direction isstopped.

In some embodiments, the delivery device can also include one or morestop members within the handle that can engage or contact the needle hubto limit or stop the travel of the needle in the distal direction.

As the needle 741 is advanced distally within the handle 735, a distalpiercing portion (not shown) of the needle 741, and in some cases, atleast the first wrap of the coiled portion of the suture 742, puncturesthe leaflet L and forms an opening in the leaflet L (see, e.g., FIG.30B). The distance the distal piercing portion of the needle 741 extendswithin the left atrium on the distal side of the leaflet L can bedetermined, for example, by the preset allowed amount of travel of theneedle 741 described above (e.g., in some embodiments, the amount oftravel can be determined at least in part by a stop member within thehandle and/or a mechanism disposed within the handle 735). In someembodiments, the delivery device 730 can be configured to advance thedistal piercing portion of the needle 741 a shorter distance into theleft atrium than as shown and described above for the embodiment ofFIGS. 6-10. For example, in some embodiments, the needle hub 743 cantravel about 6 mm (about 0.25 inches). In some embodiments, the needlecan be extended outside of the distal end of the delivery device (e.g.,beyond the end effector) half the distance that is shown and describedfor the embodiment of FIGS. 6-10. In some embodiments, the needle can beextended outside the delivery device a distance of 5-8 mm (about 0.2-0.3inches) (e.g., about 6 mm (about 0.25 inches)).

With a portion of the needle 741 disposed within the left atrium, anactuator (not shown) can be actuated and/or moved to cause the pusherhub 739 and in turn the pusher 737 to move distally within the handle735 and relative to the needle 741 and needle hub 743, as shown by FIG.30C. In this manner, the distal end portion of the pusher 737 can urge,push, or otherwise move the coiled portion of the suture 742 (e.g., thedistal anchor 740) off and distal to the needle 741, as described infurther detail herein. For example, in some embodiments, with the endeffector 733 in contact with the proximal side of the mitral valveleaflet L, and the needle 741 in a fixed position relative to the pusher737, the pusher 737 can be moved distally about 17 mm (about 0.65inches).

As the pusher 737 is moved distally, and with the suture catch 746, theneedle 741 and the needle hub 743 in fixed positions relative to thepusher 737, a distal end of the pusher 737 moves or pushes the distalcoiled portion of the suture 742 (e.g., distal anchor 740) over thedistal end of the needle 741 and further within the left atrium of theheart on a distal side of the mitral leaflet (see FIG. 30C). In otherwords, the distal end of the pusher 737 and the distal coiled portion ofthe suture 742 extend beyond the distal end of the needle 741. Forexample, in some embodiments, at least half a length of the distalcoiled portion of the suture 742 extends beyond the distal end of theneedle 741. In some embodiments, at least three quarters of the lengthof the distal coiled portion of the suture 742 extends beyond the distalend of the needle 741. In other embodiments, the entire length of thedistal coiled portion of the suture 742 extends beyond the distal end ofthe needle 741. To allow the distal coiled portion of the suture 742(e.g., distal anchor 740) to slide relative to and eventually off theneedle 741, when the suture 742 is loaded within the delivery device730, there can be slack formed in the suture 742 between the distalcoiled portion of the suture 742 and the suture lock within the suturecatch 746.

After the distal coiled portion of the suture 742 is moved to the distalside of the leaflet L, the needle hub 743 and the needle 741 are movedproximally relative to the pusher 737, pulling the suture 742 (e.g.,suture strands extending from the coiled portion of the suture 742)through the pusher 737 to form the bulky knot configuration (as shown inFIG. 30D) of the distal anchor 740 by approximating opposite ends of thecoils of the elongated coil portion of the suture 742 towards eachother, to form one or more loops. As shown in FIG. 30D, by pulling onthe proximal ends of the suture 742, the coils are pulled against thedistal end of the pusher 737 to form the knot. After the distal anchor740 has formed a knot, the proximal end portions of the suture 742 canbe released from the suture catch 746 and the delivery device 730 can bewithdrawn proximally, leaving the distal anchor 740 disposed on thedistal side of the leaflet L (as shown in FIG. 30E), and two lengths orstrands of the suture 732 extending out of the heart. In other words,with the suture 742 released from the suture catch 746, the deliverydevice 730 can be slid over the suture 742 for removal.

In some embodiments, after the distal anchor 740 has formed a knot, andthe proximal end portions of the suture 742 are released from the suturecatch 746, the needle 741 and/or the pusher 737 can be withdrawnproximally within and relative to the outer tube 731. In some instances,the needle 741 and/or the pusher 737 are withdrawn proximally into theouter tube 731 before the delivery device 730 is withdrawn proximally,while in other instances, the needle 741 and/or the pusher 737 arewithdrawn proximally into the outer tube 731 as the delivery device 730is withdrawn proximally.

As described above for previous embodiments, the lengths or strands ofthe suture 742 between the distal anchor 740 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 742 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. As a result, one or more anchor-tether apparatuses (e.g.,anchor-tether apparatus 145) as described above are each anchored on adistal side of a leaflet with a distal anchor 740 and secured to theapex of the heart with a proximal anchor via the tether 742.Alternatively, if one or more anchor-tether apparatuses is attached toboth mitral valve leaflets, an anchor-tether apparatus attached to eachleaflet can be secured together in the heart by tying them together withknots or by another suitable attachment member (not shown), creating anedge-to-edge repair to decrease the septal-lateral distance of themitral valve orifice. The two attached anchor-tether apparatuses can beleft loose or tensioned to create a “facilitated” edge-to-edge repairbefore being secured to an outer surface of the heart with a proximalanchor.

In some embodiments, alternatively or in addition to providing slack inthe suture, a spring can be disposed in the handle and coupled to thesuture between the distal coiled portion of the suture (e.g., the distalanchor) and the suture lock, which can expand longitudinally as thedistal anchor is moved distally relative to the handle as describedabove.

Examples of Distal Anchors and Forming Such Distal Anchors

FIG. 31 shows a schematic illustration of a distal anchor 840 shown inan elongated coiled configuration. The distal anchor 840 can bedelivered and deployed within a heart using any of the delivery devicesdescribed herein. For ease of explanation, the distal anchor 840 isshown and described with reference to a first section 860 of the suture842 and a second section 870 of the suture 842. The first section 860has a first portion 861 (as shown in dashed line for ease ofillustration) and a second portion 862 including a first coil 863 formedof multiple turns about the exterior of the distal end portion 832 ofthe delivery device 830. The first coil 863 has a proximal end 864 and adistal end 865. The second portion 862 of the first section 860 has afirst end 866 at the distal end 865 of the first coil 863.

The second section 870 has a second portion 872 with a first end 876,and extends proximally from the first end 866 of the first section 860through an interior of the first coil 863 (and through the lumen of thedistal end portion 832 of the delivery device 830) to the proximal end864 of the first coil 863. The second section 870 also includes a loopforming segment 877 that extends distally from a first end 878 of theloop forming segment 877 at the proximal end 864 of the first coil 863along the outside of the first coil 863 to the distal end 865 of thefirst coil 863, and extends proximally through the interior of the firstcoil 863 (and through the lumen of the distal end portion 832 of thedelivery device 830) to the proximal end 864 of the first coil 863 at asecond end 879 of the loop forming segment 877.

The second portion 872 of the second section 870 includes a second coil873 formed of multiple turns about the exterior of the distal endportion 832 of the delivery device 830 proximal to the first coil 863,and has a proximal end 874 and a distal end 875. The second portion 872of the second section 870 extends proximally from the first end 876 ofthe second portion 872 through the interior of the second coil 873 (andas shown in FIGS. 32A-32E, e.g., through the lumen of the distal endportion 832 of the delivery device 830) to the proximal end 874 of thesecond coil 873. The first end 878 of the loop forming segment 877 ofthe second portion 872 of the second section 870 extends from the distalend 875 of the second coil 873.

The second portion 862 of the first section 860 has a loop formingsegment 867 that extends from a first end 868 of the loop formingsegment 867 of the second portion 862 of the first section 860proximally from the proximal end 864 of the first coil 863 along theoutside of the second coil 873 to the proximal end 874 of the secondcoil 873 and extends distally through the interior of the second coil873 (and as shown in FIGS. 32A-32E, e.g., through the lumen of thedistal end portion 832 of the delivery device 830) to the distal end 875of the second coil 873 at a second end 869 of the loop forming segment867 of the second portion 862 of the first section 860. The firstportion 861 of the first section 860 extends proximally from the secondend 869 of the loop forming segment 867 of the second portion 862 of thefirst section 860.

FIGS. 32A-32E illustrate in sequence the formation of the distal anchor840 of FIG. 31 about an exterior of a needle 841 of a delivery device(not shown) and in an elongated coiled configuration (FIG. 32E). Theneedle 841 defines a lumen L therethrough and a slot (not shown) incommunication with the lumen L. To form the distal anchor 840 about theneedle 841, the second portion 872 of the second section 870 of thesuture 842 is routed through the lumen L of the needle 841 (see, e.g.,FIG. 32A). Next, the second portion 862 of the first section 860 of thesuture 842 is wrapped about the needle 841 to form the first coil 863(see, e.g., FIG. 32B). Similarly, the second portion 872 of the secondsection 870 of the suture 842 is wrapped about the needle 841 proximateto the first coil 863 to form the second coil 873 (see, e.g., FIG. 32C).

After formation of the first coil 863 and the second coil 873 about theneedle 841, the loop forming segment 867 of the second portion 862 ofthe first section 860 is formed by routing proximally the sectionportion 862 of the first section 860 of the suture 842 from the proximalend 864 of and exterior to the first coil 863 towards the proximal end874 of the second coil 873 (see, e.g., FIG. 32C), and then extendingdistally through the interior of the second coil (see, e.g., FIG. 32D).In a similar manner, the loop forming segment 877 of the second portion872 of the second section 870 is formed by routing distally the secondportion 872 of the second section 870 of the suture 842 from the distalend 875 of the second coil 873 towards the distal end 865 of the firstcoil 863 (see, e.g., FIG. 32C), and then extending proximally throughthe interior of the first coil 863 to the proximal end 864 of the firstcoil 863 (see, e.g., FIG. 32D). The first portion 861 of the firstsection 860 of the suture 842 and the first portion 871 (as shown indashed line for ease of illustration) of the second section 870 of thesuture 842 extends from the lumen L of the needle 841 through the slot(not shown) of the needle 841 to an area external to the needle 841 suchthat each portion 861, 871 can be manipulated (e.g., pulled proximally)to form the knot, as described above.

FIGS. 33A-33D illustrate an example method of preparing a deliverydevice 930 to deliver a distal anchor 940 (e.g., and to form a bulkyknot distal anchor) to be disposed on a distal side of a mitral valveleaflet. The delivery device 930 can be constructed the same as orsimilar to, and function the same as or similar to, for example, thedelivery device 430 or any other delivery device described herein. Itshould be understood that for features and functions not specificallydiscussed with respect to the delivery device 930, those features andfunctions can be the same as or similar to the delivery device 430 orany of the delivery devices described herein.

The guide member 955 is configured to be coupled to the proximal end ofa pusher hub 939 as illustrated by arrow A in FIG. 33A and disposedwithin a lumen defined by the biasing member 990 shown in FIG. 30B. Asillustrated in FIG. 33B, the biasing member 990 is configured to be slidover the needle 941 that is coupled to a needle hub (not shown) disposedwithin a plunger 948.

To couple the pusher hub 939 to the plunger 948, the pusher hub 939 isslid over the needle 941 towards the distal end of the plunger 948, asshown by arrow B in FIG. 33C, until the guide member 955 and the biasingmember 990 are inserted into a lumen defined by the plunger 948 and thetabs 985 of the pusher hub 939 are aligned with corresponding slots (notshown) defined by the plunger 948. As the pusher hub 939 is slid towardsand eventually coupled to the plunger 948, the biasing member 990 iscompressed or otherwise loaded with potential energy. Although not shownin FIGS. 33A-33D, the delivery device 930 can include a handle, andsimilar to as described herein with respect to the tabs 485 and thehandle 435 of FIGS. 17A and 18A, when the pusher hub 939 is coupled tothe plunger 948 (as shown by FIG. 33D), the tabs are compressed by theinner walls of the handle. As illustrated in detailed view by FIG. 33E,the needle 941 is movably disposed within the lumen defined by thepusher 937.

FIGS. 34A-34H illustrate an example method of forming the distal anchor940 in an elongated coiled configuration (FIG. 34H) about an exterior ofthe needle 941. The distal anchor 940 (formed of a suture 942) and theneedle 941 can be constructed similar to or the same as and functionsimilar to or the same as any of the distal anchors and needlesdescribed herein with respect to previous embodiments. The needle 941defines an interior lumen L, and a distal portion of the needle 941includes a slot SL in communication with the lumen. As shown in FIG.34A, the second portion 972 of the second section 970 of the suture 942is routed through the slot SL of the needle 941 and between the knotrings 980. The knot rings 980 (e.g., silicone O-rings) are disposedabout the suture 942 and the needle 941 to secure the suture 942 to andwithin the slot SL of the needle 941. In this manner, the knot rings 980define the outer edges (or the distal end 965 of the first coil 963 andthe proximal end 974 of the second coil 973) of the distal anchor 940,and can secure the suture 942 such that the first coil 963 and thesecond coil 973 can be formed about the needle 941.

To form the first coil 963 and the second coil 973, the needle 941 isrotated such that the free ends (or the second portion 962 of the firstsection 960 and the second portion 972 of the second section 970) of thesuture 942 form multiple turns about the exterior of the needle 941, asshown in FIG. 34B. Next, the loop forming segment 967 of the secondportion 962 of the first section 960 is formed by routing proximally thesecond portion 962 of the first section 960 of the suture 942 from theproximal end 964 of and exterior to the first coil 963 towards theproximal end 974 of the second coil 973, and then extending distallythrough the interior of the second coil 973 to the distal end 975 of thesecond coil 973, as shown in FIG. 34C. In a similar manner, the loopforming segment 977 of the second portion 972 of the second section 970is formed by routing distally the second portion 972 of the secondsection 970 of the suture 942 from the distal end 975 of the second coil973 towards the distal end 965 of the first coil 963, and then extendingproximally through the interior of the first coil 963 to the proximalend 964 of the first coil 963, as shown in FIG. 34D.

To further prepare the distal anchor 940 for delivery to a heart, asdescribed in previous embodiments, the loop forming segments can beshortened and/or tightened by pulling the first portion 961 of the firstsection 960 of the suture 942 and the first portion 971 of the secondsection 970 of the suture 942. Such a configuration is shown in FIG.34E. Once the loop forming segments 967, 977 are formed, the knot rings980 can be removed from the needle 932 and the suture 942. Upon removalof the knot rings 980, the loop forming segments 967, 977 can be furthershortened or tightened, as shown in FIGS. 34F and 34G. Next, the firstportion 961 of the first section 960 of the suture 942 and the firstportion 971 of the second section 970 of the suture 942 can be routedproximally into a distal end of the interior lumen L of the needle 941and proximally through the interior lumen L, as shown in FIGS. 34G and34H.

In some embodiments, a snare 993 can be used to facilitate routing ofthe suture 942 and forming of the distal anchor 940, as illustrated inFIGS. 34C, 34D, and 34G. For example, the snare 993 can be used to routethe first portion 961 of the first section 960 and the first portion 971of the second section 970 into the interior lumen L of the needle andproximally through the interior lumen L.

Examples of Flattened Distal Anchors and Forming Such Flattened DistalAnchors

In some instances, when deployed, a proximal portion or the base of thedistal anchor 940 may form a curved or “V-shaped” formation, asindicated by angle α illustrated in FIG. 34I. With the V-shapedformation, empirical data indicates that the distal anchor 940 whendeployed and delivered to a leaflet or annulus can withstand a pull-outforce of about 9 N (about 2 pound-force (lbf)). Said another way,empirical data indicates that a force above about 11.5 N (about 2.6 lbf)applied to the distal anchor 940 via the suture 942 in a proximaldirection may cause the distal anchor 940 to be pulled through theopening in the leaflet or annulus. To limit or prevent the distal anchor940 from being pulled through the opening in the leaflet or annulusthrough which it was delivered, the pull-out force that the distalanchor 940 can withstand can be increased.

FIGS. 34K-34AA illustrate an example method of forming the distal anchor940 in an elongated coiled configuration about the exterior of theneedle 941 such that the proximal portion or base of the distal anchor940 when deployed and delivered has a flattened formation, as indicatedby angle α illustrated in FIG. 34J. With the flattened formation,empirical data indicates that the distal anchor 940 when deployed anddelivered to a leaflet or annulus can withstand a pull-out force ofabout 12 N (about 2.7 lbf) to about 14 N (about 3.2 lbf). For ease ofexplanation, this method is described and illustrated beginning with thedistal anchor 940 in the elongated coiled configuration about theexterior of the needle 941 as illustrated in FIG. 34K. Disposing thedistal anchor 940 in the elongated coiled configuration about the needle941 in this manner is shown and described with respect to FIGS. 34A-34F.

With the distal anchor 940 disposed as shown in FIG. 34K, the snare 993can be used to route the first portion 971 of the second section 970 ofthe suture 942 proximally along the exterior of the second coil 973(FIGS. 34L and 34M), into the slot SL of the needle 941, distallythrough the proximal end 974 of the second coil 973, and out a portionof the second coil 973 between the distal end 975 and the proximal end975 of the second coil 973 (e.g., the middle of the coil 973; FIG. 34N),forming a first loop 1L. Similarly, as illustrated in FIGS. 340-34R, thesnare 993 can be used to route the first portion 961 of the firstsection 960 of the suture 942 distally along the exterior of the firstcoil 977, into the slot SL of the needle 941, proximally through thedistal end 965 of the first coil 977, and out a portion of the firstcoil 977 between the distal end 965 and the proximal end 964 of thefirst coil 977 (e.g., the middle of the coil 977, shown in FIG. 34Q),forming a second loop 2L.

After forming both the first loop 1L and the second loop 2L, as shown byFIGS. 34L-34R, the method further includes crossing the free ends of thesuture 942 and routing the free ends through opposing loops. Morespecifically, as shown in FIG. 34T, the first portion 961 of the firstsection 960 of the suture 942 is crossed with the first portion 971 ofthe second section 970 of the suture 942 and routed through the firstloop 1L, and the first portion 971 of the second section 970 of thesuture 942 is crossed with the first portion 961 of the first section960 of the suture 942 and routed through the second loop 2L.

Next, the first loop 1L and the second loop 2L can be shortened andtightened, as shown in FIG. 34U, by pulling on the free ends (961 and971) of the suture 942. Next, the first portion 961 of the first section960 of the suture 942 and the first portion 971 of the second section970 of the suture 942 can be routed proximally into a distal end of theinterior lumen L of the needle 941 and proximally through the interiorlumen L, as shown in FIGS. 34V-34X. Creating the distance D between thefree ends of the suture 942, as indicated in FIG. 34R, helps flatten theangle α of the base of the distal anchor 940 when deployed as describedabove and illustrated in FIG. 34J, thereby increasing the force requiredto pull the distal anchor 940 through the opening in the leaflet orannulus through which it was delivered.

A larger holding force is particularly desirable when implantingartificial chordae in the annulus of the heart to remodel, e.g., ascompared to implanting artificial chordae near the free edge of theleaflet, because much of the forces during systole in a normalfunctioning heart are applied to the secondary and tertiary cords ratherthan the primary cords. This often occurs at least in part because theprimary cords help to align the leaflets during systole, and once theleaflets come into contact or coapt, the leaflets absorb much of theload caused by contraction of the heart, thereby relieving the primarycords of high loads.

In an alternative embodiment, using any of the distal anchors describedabove, a collar (not shown) can be slidably disposed about the free endsof the suture (e.g., first portion 961 and first portion 971) after thedistal anchor is formed in its elongated configuration about the needleand before the free ends of the suture are routed proximally through thelumen of the needle. Including the collar in this manner can maintainthe portions of the suture extending from the distal anchor in closeproximity and thus limit or prevent otherwise less-controlled suturesfrom undesirably widening the hole formed in the leaflet and/or annulus(e.g., the hole through which the distal anchor was delivered). Thecollar could be sized and shaped in any suitable manner, and formed ofany suitable material. For example, in some embodiments, the collarcould be about 2 mm to about 3 mm of ePTFE tube.

Other Example Embodiments of Distal Anchors

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 940 described above are replacedby a single flexible tube. Such an embodiment of a distal anchor isillustrated in FIGS. 35 and 36. FIG. 35 illustrates a distal anchor 1040in an elongated delivery configuration, and FIG. 36 illustrates thedistal anchor 1040 in a deployed configuration. In this embodiment, theflexible tube 1044 has a distal portion 1045, and a proximal portion1056, and a slit 1046 separating the distal portion 1045 from theproximal portion 1056. In an alternative embodiment, instead of a singleflexible tube 1044, the anchor 1040 can be formed with a separate distaltube and proximal tube (not shown), separated by a gap, rather than apartial circumference slit in a middle portion of a single flexibletube, as shown in FIG. 35. The suture 1043 is routed into and throughthe slit 1046, into a lumen of the flexible tube 1044, extendingdistally through the lumen from the slit 1045 towards and through adistal end 1065 of the distal portion 1045, then extending proximallyalong the exterior of the flexible tube 1044 towards and through aproximal end 1074 of the proximal portion 1056, then extending distallyinto and through the lumen of the flexible tube 1044 towards and throughthe distal end 1065 of the distal portion 1045, then extendingproximally along the exterior of the flexible tube 1044 towards andthrough the proximal end 1074 of the proximal portion 1056, and thenextending distally through the lumen of the flexible tube 1044 towardsand through the slit 1045 and outside of the flexible tube 1044, asshown in FIG. 35.

Similar to the knot distal anchors described above with respect toprevious embodiments, the distal anchor 1040 can be deployed in asimilar manner using the delivery devices described above with respectto those embodiments. For example, the distal anchor 1040 can bedelivered in the elongate configuration (FIG. 35) and moved to thedeployed configuration (FIG. 36) by pulling the suture strands 1042proximally to deflect the distal end 1065 of the distal portion 1045 ofthe flexible tube 1044 laterally with respect to a proximal end 1064 ofthe distal portion 1045 of the flexible tube 1044 to draw the proximalend 1064 and the distal end 1065 of the distal portion 1045 of theflexible tube 1044 towards each other to form a loop L as shown in FIG.36. Similarly, the suture strands 1042 can be pulled proximally todeflect the distal end 1075 of the proximal portion 1056 of the flexibletube 1044 laterally with respect to a proximal end 1074 of the proximalportion 1056 of the flexible tube 1044 to draw the proximal end 1074 andthe distal end 1075 of the proximal portion 1056 of the flexible tube1044 towards each other to form a loop L as shown in FIG. 33.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby a T-fastener, as shown in an elongated delivery configuration in FIG.37. Similar to the knot distal anchor 240 described above, the distalanchor (or T-fastener) 1140 can be deployed in a similar manner usingany of the delivery devices described above with respect to previousembodiments. For example, the distal anchor 1140 can be coupled to asuture or sutures 1142 and removably coupled to or otherwise in operablecontact with a pusher 1134. The distal anchor 1140 can be delivered inthe elongate configuration and moved to the deployed configuration bypulling the suture 1142 proximally to rotate the distal anchor 1140 suchthat the distal anchor 1140 is non-parallel with respect to the pusher1134, the distal end portion of the delivery device 1130, and/or thesuture 1142. Simultaneously, the distal anchor 1140 can be decoupled orotherwise separated from (not shown) the pusher 1134 as the pusher 1134is moved distally relative to a handle (not shown) of the deliverydevice and the suture 1142 is pulled proximally.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor, as shown in FIGS. 38A-38D. FIG. 38Aillustrates the distal anchor 1240 in an elongated deliveryconfiguration disposed within a lumen defined by and disposed throughthe distal end portion 1232 of the delivery device. FIG. 38B illustratesthe distal anchor 1240 in the elongated deliver configuration anddisposed outside of and distal to the distal end portion 1232 of thedelivery device. FIGS. 38C and 38D illustrate the distal anchor 1240 ina deployed configuration in side and perspective view, respectively.Similar to the knot distal anchor 240 described above, the distal anchor1240 can be deployed in a similar manner using any of the deliverydevices described above with respect to previous embodiments. Forexample, the distal anchor 1240 can be coupled to a suture 1242 (ordisposed about the suture 1242 such that the suture 1242 extends througha lumen defined by the distal anchor 1240) having a stopper 1290disposed at a distal end of the suture 1242. The suture 1242 isremovably coupled to or otherwise in operable contact with a pusher1234. The distal anchor 1240 can be delivered in the elongateconfiguration (see, e.g., FIGS. 38A and 38B) and moved to the deployedconfiguration by pulling the suture 1242 proximally and/or moving thepusher 1234 distally as shown in FIGS. 38C and 38D. In this manner, boththe stopper 1290 and the pusher 1234 can collectively facilitate thetransition of the distal anchor 1240 from the elongated deliveryconfiguration to the radially expanded deployed configuration.

In another embodiment of a distal anchor, the expandable distal anchor1240 described above is replaced by a double expandable distal anchor,as shown in FIGS. 39A-39C. FIG. 39A illustrates the distal anchor 1340in an elongated delivery configuration. FIG. 39B illustrates the distalanchor 1340 in a partially deployed configuration. FIG. 39C illustratesthe distal anchor 1340 in a deployed configuration. Similar toexpandable distal anchor 1240 described above, the distal anchor 1340can be deployed in a similar manner using, for example, any of thedelivery devices described above with respect to previous embodiments.For example, the distal anchor 1340 can be disposed about a suture 1342such that the suture 1342 extends through a lumen defined by the distalanchor 1340, and removably coupled to or otherwise in operable contactwith a pusher (not shown). The distal anchor 1340 can be delivered inthe elongate configuration (see, e.g., FIG. 39A) and moved to thedeployed configuration (see, e.g., FIGS. 39B and 39C) by pulling thesuture 1342 proximally and/or moving the pusher (not shown) distally. Inthis embodiment, the distal anchor 1340 includes two slits. As thesuture 1342 is pulled proximally and/or the pusher (not shown) is moveddistally, the slits facilitate expansion of two portions of the distalanchor 1340, as shown in FIG. 39B. In its deployed configuration, theends of the first slit and the ends of the second slit are brought intoor nearly into contact with one another, as shown in FIG. 39C tomaximize the expansion of the two portions of the distal anchor 1340.

In use, in some embodiments, the distal anchor 1340 is delivered in theelongate configuration (see, e.g., FIG. 39A) through an opening in aleaflet (e.g., a prolapsed segment of a native mitral valve leaflet)until a medial portion 1341 of the distal anchor 1340 is disposed in theopening of the leaflet and a first slit is disposed in the left atriumof the heart and the second slit is disposed in the left ventricle ofthe heart. The distal anchor 640 is then moved into its deployedconfiguration (see, e.g., FIGS. 39B and 39C) such that the two portions(defined in part by the slits) expand radially and/or laterally. In thismanner, the two portions of the distal anchor 1340 can collectivelygrab, grasp, sandwich, or otherwise maintain a portion of the nativevalve leaflet therebetween. In addition to operably coupling the distalanchor 1340 to the native valve leaflet, the distal anchor 1340 whendeployed provides a seal across the opening of the leaflet to prevent orotherwise limit any fluid flow through the opening. In some embodiments,the portions of the distal anchor 1340 can be deployed (e.g., expanded)simultaneously, while in other embodiments the portions of the distalanchor 1340 can be deployed sequentially, e.g., the distal portion canbe deployed at a first time and the proximal portion can be deployed ata second time after the first time, or vice versa.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor (or umbrella anchor), as shown in FIGS.40A-40C. FIG. 40A illustrates the distal anchor 1440 in an elongatedcollapsed delivery configuration and proximate to a distal end portion1432 of a delivery device. FIG. 40B illustrates the distal anchor 1440in a partially deployed configuration. FIG. 40C illustrates the distalanchor 1440 in a deployed or expanded configuration and disposed distalto a valve leaflet VL. In this embodiment, during delivery of the distalanchor 1440, the interior walls of the distal end portion 1432 canretain the distal anchor 1440 in its elongated delivery configurationwhen the distal anchor 1440 is disposed within a lumen defined by thedistal end portion 1432. When in the elongated delivery configuration,an open end portion 1440 a of the distal anchor 1440 is disposedproximal to a rounded distal end 1440 b of the distal anchor as shown inFIG. 40A. Similar to distal anchor 240 described above, the distalanchor 1440 can be deployed in a similar manner using any of thedelivery devices described above with respect to previous embodiments.For example, the distal anchor 1440 can be coupled to a suture 1442 andremovably coupled to or otherwise in operable contact with a pusher1434. The distal anchor 1440 can be delivered in the elongateconfiguration (see, e.g., FIG. 40A), and moved to the deployedconfiguration (see, e.g., FIGS. 40B and 40C) by pulling the suture 1442proximally and/or moving the pusher 1434 distally. As the distal anchor1440 is moved distally and the open end portion 1440 a exits the distalend portion 1432 of the delivery device, the distal anchor 1440 isallowed to expand (e.g., the open end 1440 a opens) towards its deployedor expanded configuration, as shown in FIG. 40B.

In an alternative embodiment, a distal anchor can be configured similarto the distal anchor 1440 except that the distal anchor can be disposedon the suture 1442 such that the open end of the umbrella shaped portionis distal to the rounded distal end of the distal anchor. In such anembodiment, the rounded distal end can define a hole through which thesuture can be extended and secured. The distal anchor can be formed withfor example a shape-memory material such that the distal anchor has abiased expanded or deployed configuration and an elongated collapsedconfiguration when constrained within a delivery device. The distalanchor can be pushed or moved out of a delivery device with, forexample, a pusher device. As the distal anchor exits a distal end of thedelivery device, the distal anchor can transition from its elongatedcollapsed configuration to its expanded, deployed or biasedconfiguration. Said another way, as the distal anchor exits the distalend of the delivery device, the open end of the distal anchor opens toits expanded or biased configuration. In this manner, the distal anchorcan transition from its delivery configuration to its deployedconfiguration as it exits the delivery device.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor, as shown in FIGS. 41A-41D. In thisembodiment, the distal anchor 1540 includes elongate members 1540 b withfree ends 1540 a and a stopper receiving section 1591. FIG. 41Aillustrates the distal anchor 1540 in an elongated deliveryconfiguration and disposed within a lumen defined by a distal endportion 1532 of a delivery device such that the free ends 1540 a ofelongate members 1540 b are disposed proximal to the stopper receivingsection 1591 of the distal anchor 1540. FIG. 41B illustrates the distalanchor 1540 in the elongated delivery configuration. FIGS. 41C and 41Dillustrate the distal anchor 1540 in a deployed configuration. In thisembodiment, a distal end portion of the suture 1542 includes a stopper1590 and the stopper receiving section 1591 of the distal anchor 1540 isconfigured to cooperatively mate with the stopper 1590. During deliveryof the distal anchor 1540, the interior walls of the distal end portion1532 can retain the distal anchor 1540 in its elongated deliveryconfiguration when the distal anchor 1540 is disposed within a lumendefined by the distal end portion 1532, as shown in FIG. 38A. Similar todistal anchor 240 described above, the distal anchor 1540 can bedeployed in a similar manner using any of the delivery devices describedabove with respect to previous embodiments. For example, the distalanchor 1540 can be coupled to a suture 1542 and removably coupled to orotherwise in operable contact with a pusher 1534. The distal anchor 1540can be delivered in the elongated configuration (see, e.g., FIG. 41A)and moved to the deployed configuration (see, e.g., FIGS. 41B and 41C)by pulling the suture 1542 proximally and/or moving the pusher 1534distally (see, e.g., FIG. 41C). In this manner, the stopper 1590 of thesuture 1542 can be moved into contact with the stopper receiving section1591, and the stopper 1590 and the stopper receiving section 1591 cancollectively facilitate the transition of the distal anchor 1540 fromthe elongated delivery configuration to the expanded deployedconfiguration.

In an alternative embodiment, a distal anchor can be configured similarto the distal anchor 1540 except that the distal anchor can be disposedon the suture 1542 such that the free ends of the elongate members aredistal to the stopper receiving section. In such an embodiment, thedistal anchor can be formed with for example a shape-memory materialsuch that the distal anchor has a biased expanded or deployedconfiguration and an elongated collapsed configuration when constrainedwithin a delivery device. The distal anchor can be pushed or moved outof a delivery device with, for example, a pusher device. As the distalanchor exits the delivery device, a distal end of the distal anchor cantransition from its elongated collapsed configuration to its expanded,deployed or biased configuration. Said another way, as the distal anchorexits the distal end of the delivery device, the free ends of theelongate members can extend radially towards the deployed or biasedconfiguration of the distal anchor. In this manner, the distal anchorcan transition from its delivery configuration to its deployedconfiguration as it exits the delivery device.

The distal anchor 1540 can be formed of any suitable material, such as,for example a malleable stainless steel, a shape memory or superelasticalloy, or a polymer. One such polymer, for example, can includepolyaryletherketones (PAEKs) such as polyetheretherketone (PEEK).Optionally, in some embodiments, a distal anchor can include or becoupled to a material (e.g., a fabric and/or polymer) that is configuredto distribute an anchor load, cover and/or seal the hole made in theleaflet, and/or promote ingrowth or an otherwise desirable biologicalresponse when the distal anchor is disposed within a heart. For example,as illustrated in FIGS. 42A and 42B, the distal anchor 1540 of FIGS.41A-41D can have such a material 1592 coupled thereto. For example, insome embodiments, the material 1592 can extend between the elongatemembers 1540 b and beyond the free ends 1540 a of the distal anchor1540, as shown in FIG. 42A. In some embodiments, the material 1592 canbe sized and shaped to replicate or nearly replicate the size and shapeof the elongate members 1540 b of the distal anchor 1540, as shown inFIG. 42B.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor, as shown in FIGS. 43A-43C. FIG. 43Aillustrates a distal end portion of the distal anchor 1640 in a deployedconfiguration. FIG. 43B illustrates a proximal end portion of the distalanchor 1640 in the deployed configuration. FIG. 43C illustrates inpartial cross-section the distal anchor 1640 in the deployedconfiguration. In this embodiment, a distal end portion of the suture1642 includes a stopper 1690. A radial support member 1694 is coupledand disposed proximal to the proximal end portion of the distal anchor1640. The radial support member 1694 can prevent or otherwise limit thedistal anchor 1640 from undesirably flipping or deflecting (1) beyond aplane defined by the stopper 1690, and/or (2) distal to the stopper1690. The radial support member 1694 can be made of any suitablematerial sufficient to provide radial support, such as, for example, anon-elastic material. In addition, as shown best in FIG. 43C, the distalanchor 1640 is pre-configured to have a slight angle.

Similar to distal anchor 240 described above, the distal anchor 1640 canbe deployed in a similar manner using any of the delivery devicesdescribed above with respect to previous embodiments. For example, thedistal anchor 1640 can be coupled to the suture 1642 and removablycoupled to or otherwise in operable contact with a pusher (not shown).The distal anchor 1640 can be delivered in the elongated configuration(not shown) and moved to the deployed configuration by pulling thesuture 1642 proximally and/or moving the pusher (not shown) distally, asshown in FIGS. 43A-43C. In this manner, the stopper 1690 of the suture1642 can be moved into contact with the distal end portion of the distalanchor 940, and as a result, can collectively facilitate the transitionof the distal anchor 1640 from the elongated delivery configuration (notshown) to the expanded deployed configuration. Although not shown, insome embodiments, the distal anchor 1640 can include radial stiffeningmembers in addition to or instead being coupled to the radial supportmember 1694.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable braid, as shown in FIGS. 44A-44E. FIG. 44A illustratesthe expandable braid distal anchor 1740 in an elongated deliveryconfiguration, FIG. 44B illustrates the distal anchor 1740 in theelongated delivery configuration with reference to a valve leaflet L,and FIG. 44C illustrates the distal anchor 1740 in cross-section in theelongated delivery configuration. FIG. 44D illustrates the distal anchor1740 in an expanded or deployed configuration with reference to a valveleaflet L, and FIG. 44E illustrates in cross-section the distal anchor1740 in the deployed configuration. In this embodiment, the expandablebraid distal anchor 1740 has a distal portion 1745, a proximal portion1756, and a distal collar 1795 disposed therebetween. The distal anchor1740 also includes a proximal collar 1796 disposed proximal to theproximal portion 1756 of the distal anchor 1740. Similar to the knotdistal anchor 240 described above, the distal anchor 1740 can bedeployed in a similar manner using any of the delivery devices describedabove with respect to previous embodiments. For example, the distalanchor 1740 can be coupled to a suture 1742. The distal anchor 1740 canbe delivered in the elongate configuration and moved to the deployedconfiguration by pulling the suture strands 1742 proximally to cause thebraided distal portion 1745 and the braided proximal portion 1756 toexpand radially, as shown in FIGS. 44D and 44E.

Prior to deployment of the expandable braid distal anchor 1740, thedistal collar 1795 can be aligned with and disposed at least partiallywithin the hole formed in the leaflet L, as shown in FIG. 44B. In thismanner, when deployed (radially expanded), the distal portion 1745 ofthe distal anchor 1740 will be disposed on the distal side of theleaflet L (e.g., within the atrium of the heart), and the proximalportion 1746 of the distal anchor 1740 will be disposed on the proximalside of the leaflet L (e.g., within the ventricle of the heart), asshown in FIG. 44D. Deployment of the distal portion 1745 and theproximal portion 1746 can be initiated in stages. For example,deployment of the distal portion 1745 can be initiated while theproximal portion 1746 is in the elongated delivery configuration, anddeployment of the proximal portion 1746 can be initiated after thedistal portion 1745 has transitioned into the deployed configuration.

Further to this example, in use, the distal anchor 1740 can be insertedinto the atrium of the heart and the distal portion 1745 can be deployedwithin the atrium. Next, the suture 1742 can be pulled proximally suchthat a proximal side surface of the distal portion 1745 of the distalanchor 1740 is brought into contact with an atrial side of the heartvalve leaflet L. In this manner, the distal portion 1745 can bemanipulated into a desirable position before the proximal portion 1746of the distal anchor 1740 is deployed. Once the distal portion 1745 issuitable positioned against the valve leaflet L, the proximal portion1746 of the distal anchor 1740 can be deployed such that a distal sidesurface of the proximal portion 1746 is brought into contact with aventricle side of the valve leaflet L, thereby securing the leaflet Lbetween the distal portion 1745 and the proximal portion 1746.

Although not shown, in some embodiments, the distal anchor 1740 caninclude a locking mechanism configured to lock, bias, or otherwisemaintain the distal anchor 1740 in its expanded deployed configuration.Further, in some embodiments, the distal portion 1745 and the proximalportion 1746 can be formed of shape memory or superelastic material suchthat its expanded deployed configuration is its unbiased configuration.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby a single flexible tube, as shown in FIGS. 45A-45C. FIG. 45Aillustrates the distal anchor 1840 in an elongated deliveryconfiguration, and FIGS. 45B and 45C illustrate the distal anchor 1840in a deployed configuration, in side view and perspective view,respectively. In this embodiment, the flexible tube 1840 has a distalportion 1845, and a proximal portion 1856, and a medial portion 1846disposed therebetween. Each portion is separated by a hinge section,e.g., a first hinge section 1897 is disposed between the distal portion1845 and the medial portion 1846, and a second hinge section 1898 isdisposed between the medial portion 1846 and the proximal portion 1856.The suture 1842 includes a stopper 1890 at its distal end, and extendstherefrom through a first aperture AP1, a second aperture AP2 and athird aperture AP3, each of which is defined by the flexible tube 1840,as shown in FIGS. 45A-45C.

Similar to the knot distal anchor 240 described above, the distal anchor1840 can be deployed in a similar manner using any of the deliverydevices described above with respect to previous embodiments. The distalanchor 1840 can be delivered in the elongate configuration and moved tothe deployed configuration by pulling the suture strand 1842 proximallyto deflect the portions 1845, 1846, 1156 about their respective hingesections 1897, 1898, as shown in FIGS. 45B and 45C. In this manner, theportions 1845, 1846, 1856 are drawn towards each other (or folded ontoone another) to form the expanded deployed configuration.

The distal anchor 1840 can be formed of any suitable material, e.g.,ePFTE or a similar biocompatible polymer. In an alternative embodiment,instead of a single flexible tube 1844, the anchor 1840 can be formed ofseparate portions and then coupled together. Further, in an alternativeembodiment, instead of three portions (e.g., distal, proximal, medial),the anchor 1840 can include any suitable number of portions (e.g., asingle portion, two portions, or four or more portions).

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby a hinged tube, as shown in FIGS. 46A and 43B. FIG. 46A illustratesthe distal anchor 1940 in an elongated delivery configuration, and FIG.46B illustrates schematically the distal anchor 1940 in a deployedconfiguration. In this embodiment, the hinged tube 1940 has a distalportion 1945, and a proximal portion 1956, and hinge sections HS tofacilitate deployment, deflection or bending of the distal portion 1945and the proximal portion 1956 at desirable sections of the distal anchor1940. A distal end portion of an elongated tube 1999 is fixedly coupledto a distal end of the distal portion 1945 of the distal anchor 1940,and extends through a lumen defined by the distal anchor 1940, out aproximal end of the proximal portion 1945 of the distal anchor 1940, andthen coupled to a suture 1942, as shown in FIG. 46A. Similar to the knotdistal anchor 240 described above, the distal anchor 1940 can bedeployed in a similar manner using any of the delivery devices describedabove with respect to previous embodiments. For example, the distalanchor 1940 can be delivered in the elongate configuration and moved tothe deployed configuration by pulling the suture strand 1942 proximally,and thereby similarly moving the elongated tube 1999 proximally with thesuture strand 1942, to deflect the hinged tube 1940 laterally withrespect to the hinge sections HS to form the deployed or expandedconfiguration, as shown in FIG. 46B.

Improving Coaptation Using Distal Anchors in Annulus and/or Leaflet

Repairing a cardiac valve (e.g., a mitral valve) by implanting a distalanchor, as described herein, is often influenced by a patient'sparticular anatomy. When the combined length of the posterior leafletand the anterior leaflet is significantly larger than the A-P dimensionof the mitral valve, the likelihood of a successful repair issignificantly higher. For example, a patient having a large posteriorleaflet is desirable, as a large posterior leaflet provides a largesurface of coaptation with the anterior leaflet, thereby providing asufficient seal when the leaflets coapt, e.g., to limit regurgitation.Conversely, a patient having a small posterior leaflet will have arelatively smaller surface of coaptation. Similarly, a patient having alarge anterior leaflet can help lead to a desirable and successfulrepair. Ultimately, the effectiveness and durability of a repair of thisnature is influenced greatly by the amount of anterior and posteriorleaflet tissue coapting together during systole. As another example,some patients have a relatively large valve orifice (e.g., the orificemay dilate over time due to illness), and as a result are prone to lessleaflet coaptation and increased regurgitation. Ensuring sufficientcoaptation is addressed by various embodiments described herein,including the following examples with reference to FIGS. 47A-53.

For example, embodiments described herein relate to implanting aplurality of distal anchors near or in an annulus of the valve (e.g.,the posterior annulus) and tensioning sutures to pull the portion of theannulus toward an opposite edge and inward into the ventricle. In someimplementations, 3 or 4 distal anchors can be implanted at or near theposterior annulus and the associated sutures can be anchored oppositethe distal anchors and tensioned to pull the posterior annulus towardsthe anterior annulus and down into the ventricle. This can effectivelyreduce the size of the orifice and increase coaptation. This can beadvantageously used in combination with distal anchors implanted in theleaflet or in isolation to treat primary as well as secondary orfunctional mitral valve regurgitation.

In some embodiments, the anchor point(s) or entry point(s) of thesutures can be offset from the apex of the heart to achieve a desirableor targeted force vector on the posterior annulus. For example, theentry point(s) can be offset about 1 cm lateral to the left anteriordescending coronary artery on the surface of the heart and about 2 cm toabout 3 cm basal from the true apex of the heart. Entry point(s) can beadjusted to achieve a targeted force vector. For example, the entrypoint(s) can be adjusted to be more basal to increase the anteriorcomponent of the force vector on the posterior annulus (e.g., thecomponent pulling towards the anterior annulus).

In addition, some embodiments can include distal anchors implanted inthe posterior leaflet in addition to distal anchors implanted in or nearthe posterior annulus. This can allow differential tensioning where thetension applied to the distal anchors implanted at the posterior annulusdiffers from the tension applied to the distal anchors implanted at theposterior leaflet. This allows for greater flexibility in treatingvarious configurations of a valve to improve coaptation.

FIGS. 47A-49D illustrate different valve configurations to demonstratedifferent treatment strategies. For example, FIGS. 47A-47C illustrateexample treatment strategies that utilize distal anchors implanted in arelatively large posterior leaflet. As another example, FIGS. 48A-48Cillustrate example treatment strategies that utilize distal anchorsimplanted in a relatively small posterior leaflet. These figures alsodemonstrate some of the difficulties that may arise in such situationswhere distal anchors are limited to being implanted at the leaflet. Asanother example, FIGS. 49A-49D illustrate example treatment strategiesthat use distal anchors implanted at the posterior annulus (e.g., FIGS.49A, 49C, and 49D) and a combination of distal anchors implanted at theposterior annulus and the posterior leaflet (e.g., FIG. 49B). Thesestrategies may advantageously be used to treat primary and secondarymitral valve regurgitation.

FIG. 47A is a schematic illustration of a heart H of a patient havingdesirable or beneficial anatomy due at least in part to a relativelylarge posterior leaflet, PL. However, the patient may experience MR dueto a prolapsed leaflet or other similar defect. Thus, it may bedesirable to adjust the posterior leaflet using the distal anchorsdisclosed herein to increase coaptation.

FIG. 47B illustrates an example treatment strategy that implantsmultiple distal anchors 2040 (e.g., 3 or 4) at or near the free edge ofthe posterior leaflet PL, and anchored with a suture 2042 at an accesssite near the apex Ap of the heart H. The distal anchors 2040 can bespaced apart along or near an edge of the posterior leaflet (e.g.,spaced apart in a dimension that is perpendicular to the plane of thefigure). In some embodiments, the distal anchors 2040 can be spacedapart about 5 mm or between about 3 mm and about 7 mm. The lateralspacing of the distal anchors 2040 along or near an edge of theposterior leaflet PL can be uniform or it can vary between distalanchors 2040 (e.g., an individual distal anchor can be spaced betweenabout 3 mm and about 7 mm from a neighboring distal anchor, and thisspacing can be the same or different for each distal anchor).

As shown in FIG. 47B, the suture 2042 is tensioned such that the freeedge of the posterior leaflet PL is pulled towards the access site andinto the ventricle V of the heart H. In some embodiments, the tensioncan be configured to result in greater than about 4 mm of availablesurface of coaptation. In some embodiments, the tension can beconfigured to pull the posterior leaflet PL far enough that the distalanchors 2040 are below the anterior leaflet AL. This can advantageouslyincrease coaptation or reduce separation between the posterior leafletPL and anterior leaflet AL to improve coaptation, separation that mayhave been caused by the distal anchors 2040 coming into contact with theanterior leaflet AL. In certain implementations, flattened distalanchors (examples of which have been described herein with reference toFIGS. 34J-34AA) may be beneficially used to reduce the profile of thedistal anchors 2040 to improve results (e.g., improved coaptation,improved resistance to being pulled through the PL, etc.).

FIG. 47C illustrates another treatment strategy that modifies the forcevector of the sutures 2042 relative to the treatment strategy of FIG.47B. This can be done to promote a larger surface of coaptation. Theaccess site can be moved laterally relative to the apex Ap of the heartH, e.g., between the branch at the left anterior descending artery (LAD)and the diagonal. Tensioning the suture 2042 at such an access site canpull or otherwise move the posterior annulus PA towards the anteriorleaflet AL, thereby reducing the distance between the anterior annulusAA and the posterior annulus PA by between about 10% and about 30%. Saidanother way, tensioning the suture 2042 in this manner can decrease thevalve orifice. Reducing the distance between the leaflets results in anincreased surface of coaptation. In some embodiments, tensioning thesuture 2042 at this access site can move the posterior annulus towardsthe anterior annulus and/or down within the ventricle to increase thesurface of coaptation.

FIG. 48A illustrates a patient may have a relatively small posteriorleaflet and/or large valve orifice to leaflet tissue ratio. In such ascenario, leaflet coaptation may remain sub-optimal even after distalanchors are implanted at the leaflet and properly tensioned.

FIG. 48B illustrates an example treatment strategy to address thisissue. Distal anchors 2040 can be implanted at or near an edge of arelatively small posterior leaflet and tensioned to improve coaptation.However, even with the distal anchors 2040 anchored at or near an edgeof the posterior leaflet PL (e.g., 3-4 distal anchors spaced along anedge of the posterior leaflet PL) and with the sutures 2042 properlytensioned and secured to the heart H lateral to the apex Ap, the surfaceof coaptation may be less than a desirable length, e.g., about 4 mm Withthis limited coaptation, the patient may be susceptible toregurgitation, e.g., blood passing between the posterior leaflet PL andthe anterior leaflet AL from the ventricle V to the atrium A, (e.g., ina direction along arrow A of FIG. 48B).

Further, in this scenario, the distal anchors 2040 are situated at theedge of the surface of coaptation. More specifically, the distal anchors2040 may be disposed between the posterior leaflet PL and the anteriorleaflet AL such that the distal anchors 2040 are in contact with bothleaflets and the left atrium, as opposed to, for example, being disposedfurther into the ventricle V and away from where the leaflets coapt (asis desirable and shown in FIGS. 47B and 47C). In a scenario where thedistal anchors 2040 are collocated with the area of coaptation, thedistal anchors 2040 may disrupt sealing between the leaflets, resultingin regurgitation. To limit such disruption, the distal anchors 2040 canhave a flattened base, examples of which are described herein withreference to FIGS. 34J-34AA. Having a flattened base allows the distalanchor 2040 to have a relatively small form factor and to be seatedflush with the atrial side of the posterior leaflet PL, thereby reducingor otherwise limiting regurgitation or blood flow between the leafletsdue to leaks surrounding the distal anchor.

FIG. 48C illustrates another treatment strategy that increases thetension on the distal anchors 2040 relative to the treatment strategyillustrated in FIG. 48B. However, although the sutures 2042 areshortened or tensioned to pull the posterior annulus towards theanterior leaflet (e.g., to reduce the orifice), shortening or tensioningthe sutures 2042 enough to displace the distal anchors 2040 from thearea of coaptation may cause the posterior leaflet PL to extend too farinto the ventricle V. This may create too large of a gap between theposterior leaflet PL and the anterior leaflet AL. Such a gap may allowregurgitation or blood flow between the leaflets from the ventricle V tothe atrium A, e.g., in a direction along arrow B.

To address concerns with respect to insufficient coaptation andregurgitation, procedures can include implanting distal anchors at theannulus, at the leaflet, or implanting distal anchors at both theannulus and the leaflet. In some embodiments, a single procedure caninclude both implanting primary cords to restore the prolapsed leafletcloser to its preferred natural position and implantingsecondary/tertiary cords in the base of the leaflet or the annulus topull the posterior annulus towards the anterior annulus. For example,one or more distal anchors can be delivered and anchored at or near theannulus of the valve, and one or more sutures extending from the one ormore distal anchors can be tensioned to pull the posterior annulustowards the anterior annulus. This can be done to reshape the valveorifice by shortening the anterior-posterior (A-P) dimension of thevalve annulus (e.g., compare FIG. 49C and FIG. 49D). Further, asdescribed with respect to embodiments herein, one or more distal anchorscan be anchored to a prolapsed leaflet (e.g., at or near the free edgeof the leaflet) and suitably tensioned to the heart. The distalanchor(s) anchored at or near the annulus and the distal anchor(s)anchored to a prolapsed leaflet can enter the heart from the samelocation (as shown in FIG. 49B) or from different locations (not shown).The tension applied to the distal anchor(s) at the annulus can bedifferent from the tension applied to the distal anchor(s) at theleaflet to allow greater flexibility in treating insufficient coaptationand regurgitation.

FIG. 49A illustrates an example of implanting a plurality of distalanchors 2140 at a posterior annulus of a patient. FIG. 49B illustratesan example of implanting a plurality of distal anchors 2140 a at aposterior annulus of a patient and a plurality of distal anchors 2140 bat a posterior leaflet of the patient. These methods can be performedusing any suitable anchor and any suitable delivery device, includingany of the anchors and delivery devices described herein.

As shown in FIG. 49A, one or more distal anchors 2140 are introducedinto the ventricle V of the heart H through an access site locatedbetween the branch at the LAD and the diagonal (e.g., lateral to theapex Ap of the heart H) and anchored to the posterior annulus PA of theheart valve. The sutures 2142 extending from the distal anchors 2140 aretensioned and anchored to the heart, as shown in FIG. 49A, causing theposterior annulus PA to move closer to the anterior annulus AA and downinto the ventricle V. This causes the A-P dimension of the valve todecrease. Reducing the anterior-posterior dimension in this mannerbrings the posterior leaflet PL closer to the anterior leaflet AL,thereby promoting sufficient coaptation between the leaflets.

Although FIG. 49A illustrates a prolapsed posterior leaflet, thisprocedure may be particularly beneficial to treat functional MR byaltering the geometry of the valve orifice. For example, FIGS. 49C and49D illustrate this treatment on a valve without prolapsed leaflets.These figures demonstrate the effect of implanting distal anchors 2140at the posterior annulus and applying tension on the distal anchors 2140using sutures 2142 to alter the valve geometry. The valve 22 is similarto the valve illustrated and described herein with reference to FIGS. 2Aand 2B. The tension on the distal anchors 2140 can be adjusted todecrease the anterior-posterior dimension of the mitral annulus topromote or to improve coaptation. The sutures 2142 can be anchored sothat the tension on the sutures 2142 is along a targeted direction(e.g., to pull the posterior annulus towards the anterior annulus).

The procedure illustrated in FIGS. 49C and 49D utilize four distalanchors 2140, but it is to be understood that any number of distalanchors may be utilized. For example, the procedure may utilize 2 ormore distal anchors, 3 or more distal anchors, 4 or more distal anchors,5 or more distal anchors, or 6 or more distal anchors. As anotherexample, the procedure may utilize less than or equal to 8 distalanchors, less than or equal to 6 distal anchors, or less than or equalto 4 distal anchors. The distal anchors 2140 can be uniformly ornon-uniformly spaced. The distal anchors can be separated by about 5 mmor between about 3 mm and about 7 mm. The distal anchors 2140 can beimplanted to cover or span the area to be adjusted (e.g., a prolapse ora dilated annulus). The number and spacing of the distal anchors 2140can be adjusted based on the size of the prolapse or annular area to beadjusted. The distal anchors 2140 can be any suitable distal anchorincluding the distal anchors disclosed herein and may be advantageouslythe flattened distal anchors described herein with reference to FIGS.34J-34AA to increase resistance to pulling pulled out. However, it mayalso be beneficial to increase the number of distal anchors to spreadthe force across a larger number or anchors and to reduce the tension onindividual distal anchors, which would allow a variety of distal anchorembodiments to be used.

The access site and the location of the distal anchors 2140 can beadjusted to create targeted force vectors on different sections of theannulus to adjust the geometry of the heart to improve coaptationbetween the leaflets. Multiple access locations can also be used toapply force vectors from multiple sites. While altering the location ofthe secondary/tertiary cords (anchor-tether apparatus) can be used indegenerative MR, it is of particular interest in treating functional MR.For treating functional MR, for example, multiple secondary/tertiarycords can be placed without implanting primary or edge cords to adjustthe natural position of the leaflet(s), examples of which are shown inFIGS. 49C and 49D.

Returning to FIG. 49A, the distal anchors 2140 can be tensioned to pullthe base of the posterior leaflet in and down. This differs from anannuloplasty that is configured to reduce the size of the annulus (e.g.,bring the annulus in) but does not move a portion of the annulus down(e.g., towards the ventricle). The entry point of the sutures 2142 canbe lateral to the left atrial coronary artery and basal from the trueapex of the heart. In some embodiments, the entry point is about 1 cmlateral of the left atrial coronary artery and about 2 cm to about 3 cmbasal from the true apex of the heart. The entry point can be adjustedto change the force vectors on the distal anchors and the resultingeffect on the posterior annulus. The entry point can also be adjustedbased on the desired or targeted modification to the valve geometry. Forexample, the entry point can be configured to be opposite the targeteddirection of tension on the annulus. While the figures show theanchor-tether apparatus passing from a lateral portion of the apicalregion across the ventricle to the posterior annulus and/or posteriorleaflet, it is to be understood that that such an anchor-tetherapparatus may pass from the medial portion of the apical region acrossthe ventricle to the anterior annulus and/or anterior leaflet. Similaranchor-tether apparatuses and methods may also be used with the aorticvalve or the pulmonary valve. In some embodiments, the sutures can haveone or more entry points and need not all use the same entry point.

FIG. 49B illustrates a procedure that implants distal anchors 2140 a inthe annulus and distal anchors 2140 b in the posterior leaflet. Thesecond set of distal anchors 2140 b can be introduced into the ventricleV of the heart H though the same incision and anchored to the leaflet(e.g., at or near the prolapsed portion and/or the free edge of theposterior leaflet PL). The sutures 2142 b extending from the distalanchors 2140 b are tensioned and anchored to the heart, causing the freeedge of the posterior leaflet PL to be drawn into the ventricle towardsthe incision, as shown in FIG. 49B. In this manner, the distal anchor2140 b can be drawn inward into the ventricle and away from the point ofcoaptation (to avoid disruption of coaptation by the distal anchor). Inaddition, drawing the distal anchor 2140 b inward can increase thesurface of coaptation, thereby improving coaptation to limit, reduce,and/or prevent regurgitation.

In some embodiments, the procedure utilizes a separate introducer forthe distal anchors 2140 a on the posterior annulus and the distalanchors 2140 b on the posterior leaflet. In some embodiments, theprocedure anchors the sutures 2142 a coupled to the posterior annulus ina location different from the location used to anchor the sutures 2142 bcoupled to the posterior leaflet. In certain embodiments, the procedureutilizes the same introducer for the distal anchors 2140 a on theposterior annulus and the distal anchors 2140 b on the posteriorleaflet. In various embodiments, the procedure anchors the sutures 2142a coupled to the posterior annulus in the same location as the locationused to anchor the sutures 2142 b coupled to the posterior leaflet.

While the distal anchors 2140 a, 2140 b can be tensioned in any suitablemanner to promote sufficient coaptation between the leaflets, in someinstances, the distal anchors 2140 a anchored to the annulus or base ofthe leaflet can be tensioned with a force different from a force withwhich the distal anchors 2140 b are anchored to the leaflet (e.g., thefree edge of the leaflet) are anchored. Further, the distal anchors 2140a, 2140 b can be delivered in any suitable order, e.g., one or moredistal anchors 2140 a can be delivered to the annulus or base of theleaflet before or after one or more distal anchors 2140 b are deliveredto the free edge of the leaflet.

As described above, such an approach can replace the more complicatedand invasive open-heart surgical approach in which an undersizedannuloplasty ring is implanted to decrease the size of the valveorifice. Further, such an approach can be used to repair heartssuffering from functional mitral regurgitation and/or degenerativemitral regurgitation.

Advantageously, the disclosed procedures differ from an annuloplasty inthat the procedure serves to change paradoxical motion of an abnormalheart to the normal motion by pulling the posterior annulus toward theanterior annulus and anterior leaflet like a normal functioning heart.For example, during systole, the annulus of a normal functioning heartmoves in a correct direction by contracting. However, in prolapse thevectors are incorrect because the chordae tendineae typically cannotpull in the correct direction, resulting in the prolapsed section of theleaflet and the associated section of the annulus rolling back out ofthe valve during contraction. Because the leaflets relax duringdiastole, a valve treated with the disclosed procedures experienceslittle or no impact on mitral inflow and there is little or no mitralstenosis. This is in contrast to a valve treated with a ring or bandwhich holds the mitral annulus in the same position during systole anddiastole increasing the gradients across the valve and occasionallycausing mitral stenosis during diastole.

Additionally, the disclosed procedures are available to a larger numberof patients than simply treating the valve with edge cords. This is dueat least in part to the ability to both pull the leaflet and theannulus. For example, by pulling the annulus more, a patient with asmaller leaflet can be treated because the leaflet needs to be pulledless to achieve coaptation. Thus, a larger number of patients may beeligible for the treatment because patients with less tissue that wouldbe ruled out under other procedures may still qualify to be treated withthe disclosed treatments.

As stated herein, the disclosed procedures may be accomplished using anysuitable delivery device, including the delivery devices disclosedherein. The procedures may also be performed with the assistance ofimaging techniques, such as ultrasound. The goal of the procedure is tosafely navigate the tip of the delivery device into the natural landingzone on the underside of the mitral annulus where the leaflet and theventricular wall come together and to atraumatically deploy a distalanchor in the annulus. In some embodiments, the procedures may benefitfrom the use of a delivery device with a modified tip for implanting ofdistal anchors in the annulus. The modified tip may have enhancedechogenicity so that the tip remains visible when up against theventricular wall and the annulus (which is mostly muscle) where othertips may disappear from ultrasound imaging increasing the risk of tissuedamage. In some embodiments, the delivery device may include enhancedechogenicity of the shaft by using different shaft surfaces (e.g., baremetal versus a PBAX sleeve) and may include markers on the shaft tobetter determine the location of the tip of the delivery device. In someembodiments, the tip of the delivery device can be configured to beatraumatic to muscle. Example configurations for the tip include a teardrop design, a “hammerhead” tip design, and a balloon design that can befilled with an echogenic fluid. The delivery systems described in FIGS.28-30, where the needle does not extend as far during anchor deployment,are particularly appropriate for delivery of distal anchors to theannulus. In some embodiments, the needle could be curved or made of ametal with shape memory such that when the needle is extended from theshaft of the device it curves back towards the center of the atrium andaway from the heart wall.

Example Empirical Results

FIGS. 50-53 illustrate empirical results from the procedure (acuteresults in the operating room) described above with respect to FIG. 47Cperformed on eleven patients. FIG. 50 shows the reduction in the A-Pdimension for each patient. As shown, the average reduction in the A-Pdimension when the beating heart was in systole was about 18% which is areduction suitable to promote proper coaptation and preventregurgitation.

FIG. 51 illustrates the reduction in the A-P dimension, annular area,and annular circumference for patient #10 (e.g., a patient with aless-than-average reduction in A-P dimension) when the heart is insystole and when the heart is in diastole, and FIG. 52 illustrates thereduction in the A-P dimension, annular area, and annular circumferencefor patient #5 (e.g., a patient with a greater-than-average reduction inA-P dimension) when the heart is in systole and when the heart is indiastole. As shown, for both patients #10 and #5, the reduction in theA-P dimension is much larger when the heart is in systole than when theheart is in diastole, indicating that the dynamic nature of the mitralvalve annulus after such a procedure mirrors the dynamic nature of ahealthy heart.

Not only was the procedure successful in the eleven patients at or nearthe time of the procedure, as shown in FIG. 53, this reduction wasimproved (e.g., increased) and ultimately stabilized from pre-dischargeto one-year post procedure in an even larger cohort of patients whichincludes the eleven patients evaluated in FIG. 50. For example, asshown, the average A-P dimension at pre-discharge was −6.4%, and theaverage A-P dimension at 30-days post-procedure was −10.8%, indicatingthat the heart healed over the 30 days and remains constant out to atleast one year.

Additional Embodiments and Terminology

While some of the distal anchors described above as being delivered to aleft ventricle of a heart, piercing a native mitral valve leaflet fromthe ventricular side to the atrial side, deploying the distal anchor onthe atrial side of the leaflet, and anchoring the distal anchor to anapex region of the heart, in other instances, the distal anchorsdescribed above can be delivered and deployed via other suitablemethods, e.g., transfemorally, transatrially and/or via an inferior venacava (IVC). For example, in some embodiments, one or more native valveleaflets can be pierced from the atrial side to the ventricular side,and the distal anchor can be delivered from the atrial side to theventricular side and deployed in the ventricle. In such embodiments, insome instances, the distal anchor can be attached or otherwise coupledto (e.g., via a suture) a second distal anchor (e.g., deployed at asecond leaflet). In some instances, the distal anchor can be anchored tothe apical region of the heart by routing a suture attached to theanchor through the area or void between the leaflets from the atrialside to the ventricular side.

It should be understood that the distal anchors described herein can bedelivered and deployed using any of the delivery devices describedherein or any other suitable delivery device. While some embodimentsdescribed herein have included delivery devices configured to deploy abulky knot distal anchor, in other embodiments, those delivery devicescan be configured to deliver and deploy any suitable distal anchor, suchas, for example, any of the distal anchors described herein withreference to FIGS. 11-13C, 31-32E, 34A-46B.

It should be understood that although in various embodiments describedherein the puncture member was shown and described as defining aninternal lumen through which an artificial chordae can extend, in otherembodiments, any of the delivery devices described herein can include apuncture member having a solid shaft along which an artificial chordaecan extend. In such embodiments, for example, a proximal end portion ofthe artificial chordae can be coupled to an actuator of the deliverydevice.

Although in various embodiments described herein, such as, for example,the embodiments described with reference to full forward deploymentsequences, a portion of the suture is illustrated and described as beingcoupled to the actuator and/or a suture catch, in alternativeembodiments, a portion (e.g., a proximal end portion) of the suture canbe coupled (e.g., fixedly coupled) to any suitable portion of thedelivery device. For example, in some embodiments, a proximal endportion of the suture can be fixedly coupled to the handle of thedelivery device.

In various embodiments described herein, to allow the distal anchor toslide relative to the actuator, when the suture is loaded within thedelivery device, there is slack in the suture between the distal anchorand the suture lock within the suture catch (or other location at whichthe proximal end portion of the suture is fixedly coupled). Inalternative embodiments, in addition to or instead of the slack, anysuitable mechanism can be used. For example, in some embodiments, aspring or the like can be coupled to the suture and a portion of thehandle of the delivery device such that the distal anchor can slide asdiscussed in further detail herein. In such alternative embodiments, thespring can be configured to provide tension to any excess suturedisposed between the distal end portion and the proximal end coupled tothe handle of the delivery device.

It should be understood that although in various embodiments describedherein the delivery device includes an outer tube and an end effector,in other embodiments, a delivery device can be constructed similar toand can function similar to any of the delivery devices describedherein, except the delivery device does not include an outer tube and anend effector. In such embodiments, for example, in some instances, thedelivery device can deliver and deploy a distal anchor in cooperationwith a separate device or devices configured to function similar to orthe same as the outer tube and/or end effectors described herein. Forexample, in some instances, an introducer valve, sheath, catheter or thelike can be used. In such instances, the puncture member and/or pusherdevice can be movably disposed within the introducer valve as thepuncture member and/or pusher device are used to delivery and deploy thedistal anchor. In some embodiments, an end effector can be disposed at adistal end portion of the introducer valve.

While various embodiments of delivery devices have been described abovewith respect to procedures conducted by a human operator (e.g., asurgeon), in some embodiments, the delivery device can be configured tooperate in conjunction with robotics used in, for example, roboticassisted surgery. Similarly stated, a robotic assisted procedure can beperformed using the delivery devices described above.

While various embodiments have been described above with respect to atrans-apical approach and via a left atrium of a heart, in someembodiments, an anchor-tether apparatus can be delivered transfemorally(e.g., using a catheter). In some instances, for example, native mitralvalve leaflets can be pierced from an atrial side to a ventricular sideof the leaflets, and the free ends of the sutures can be securedtogether (e.g., an edge-to-edge repair). In other instances, as anotherexample, after piercing a native mitral valve leaflet from the atrialside to the ventricular side of the leaflet, the free end of the suturecan extend beyond the free edge of the leaflet towards the ventricle andbe secured to the ventricular wall or through the apex of the heart andsecured outside of the heart, as described with respect to previousembodiments. As a further example, in some instances, the anchor-tetherapparatus can be delivered transfemorally, and the delivery device canpierce the native mitral valve leaflet from the ventricular side to theatrial side, and the sutures can be secured together or routed into theventricle and secured to the ventricle wall.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations. The embodimentsdescribed herein can include various combinations and/orsub-combinations of the functions, components and/or features of thedifferent embodiments described.

The present disclosure describes various features, no single one ofwhich is solely responsible for the benefits described herein. It willbe understood that various features described herein may be combined,modified, or omitted, as would be apparent to one of ordinary skill.Other combinations and sub-combinations than those specificallydescribed herein will be apparent to one of ordinary skill, and areintended to form a part of this disclosure. Various methods aredescribed herein in connection with various flowchart steps and/orphases. It will be understood that in many cases, certain steps and/orphases may be combined together such that multiple steps and/or phasesshown in the flowcharts can be performed as a single step and/or phase.Also, certain steps and/or phases can be broken into additionalsub-components to be performed separately. In some instances, the orderof the steps and/or phases can be rearranged and certain steps and/orphases may be omitted entirely. Also, the methods described herein areto be understood to be open-ended, such that additional steps and/orphases to those shown and described herein can also be performed.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense, as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to.” The word “coupled”, as generally usedherein, refers to two or more elements that may be either directlyconnected, or connected by way of one or more intermediate elements.Additionally, the words “herein,” “above,” “below,” and words of similarimport, when used in this application, shall refer to this applicationas a whole and not to any particular portions of this application. Wherethe context permits, words in the above Detailed Description using thesingular or plural number may also include the plural or singular numberrespectively. The word “or” in reference to a list of two or more items,that word covers all of the following interpretations of the word: anyof the items in the list, all of the items in the list, and anycombination of the items in the list. The word “exemplary” is usedexclusively herein to mean “serving as an example, instance, orillustration.” Any implementation described herein as “exemplary” is notnecessarily to be construed as preferred or advantageous over otherimplementations.

The disclosure is not intended to be limited to the implementationsshown herein. Various modifications to the implementations described inthis disclosure may be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. The teachings of the invention provided herein can beapplied to other methods and systems, and are not limited to the methodsand systems described above, and elements and acts of the variousembodiments described above can be combined to provide furtherembodiments. Accordingly, the novel methods and systems described hereinmay be embodied in a variety of other forms; furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made without departing from the spiritof the disclosure. The accompanying claims and their equivalents areintended to cover such forms or modifications as would fall within thescope and spirit of the disclosure.

What is claimed is:
 1. An apparatus comprising: a pusher having a distalend; a needle having a distal portion, the needle slidably disposedwithin the pusher with the distal portion of the needle extending fromthe distal end of the pusher; and a suture having a first section and asecond section, each of the first section and the second section havinga first portion and a second portion, the second portion of each sectionincluding a coil that has a proximal end and a distal end and beingformed of multiple turns about an exterior of the needle, a first end ofthe second portion of the first section being at the distal end of thecoil of the first section; a first end of the second portion of thesecond section coupled to the first end of the second portion of thefirst section; the first section forming a first loop forming segmenthaving a first end at the proximal end of the first coil, a second endat the distal end of the first coil, and being routed proximallyexternal to the second coil and distally internal to the second coil;the second section forming a second loop forming segment having a firstend at the distal end of the second coil, a second end at the proximalend of the first coil, and being routed distally external to the firstcoil and proximally internal to the first coil; the second sectionforming a first loop by routing the first portion of the second sectionproximally along the exterior of the coil of the second section anddistally through the proximal end of the coil of the second section,internal to the coil of the second section, and out a portion of thecoil of the second section between the distal end and the proximal endof the coil of the second section; the first section forming a secondloop by routing the first portion of the first section distally alongthe exterior of the coil of the second section and proximally throughthe distal end of the coil of the first section, internal to the coil ofthe first section, and out a portion of the coil of the first sectionbetween the distal end and the proximal end of the coil of the firstsection; the first portion of the first section being crossed with thefirst portion of the second section and routed through the first loop;and the first portion of the second section being crossed with the firstportion of the first section and routed through the second loop.
 2. Theapparatus of claim 1, wherein the suture is configured for the coil ofthe first section and the coil of the second section to be formed into aflattened loop by withdrawing the needle proximally through the coil ofthe first section and the coil of the second section such that thepusher separates the coil of the first section and the coil of thesecond section from the needle.
 3. The apparatus of claim 2, wherein theapparatus is further configured to form the flattened loop bywithdrawing the first portion of the second section relative to thedistal end of the pusher to draw the second end of the second loopforming segment proximally from the proximal end of the coil of thefirst section to deflect the distal end of the coil of the first sectionlaterally with respect to the proximal end of the coil of the firstsection and to draw the proximal end and the distal end of the coil ofthe first section towards each other to form a portion of the flattenedloop.
 4. The apparatus of claim 3, wherein the apparatus is furtherconfigured to form the flattened loop by withdrawing the first portionof the first section relative to the distal end of the pusher to drawthe second end of the first loop forming segment proximally from theproximal end of the coil of the second section to deflect the distal endof the coil of the second section laterally with respect to the proximalend of the coil of the second section and to draw the proximal end andthe distal end of the coil of the second section towards each other toform a portion of the flattened loop.
 5. The apparatus of claim 1,wherein the needle defines an interior lumen and a distal portion of theneedle includes a slot in communication with the lumen.
 6. The apparatusof claim 1 further comprising a handle.
 7. The apparatus of claim 6,wherein the needle and the pusher are configured to move relative to thehandle.
 8. The apparatus of claim 1 further comprising an elongate outertube forming a lumen, the needle and the pusher movably disposed withinthe lumen formed by the elongate outer tube.
 9. The apparatus of claim 8further comprising a distal end effector coupled to a distal end portionof the elongate outer tube, the distal end effector configured todistribute a force applied by the elongate outer tube during deploymentof a distal anchor formed from the suture.
 10. The apparatus of claim 1,wherein the suture is configured to form a distal anchor comprising aflattened loop.
 11. A delivery device configured to deliver and deploy adistal anchor within a heart of a patient, the delivery devicecomprising: an elongate outer tube forming a lumen; a handle coupled toa proximal end portion of the elongate outer tube; an elongate pushermovably disposed within the lumen formed by the elongate outer tube, theelongate pusher forming a lumen; a pusher hub coupled to the handle anda proximal end portion of the elongate pusher, the pusher hub configuredto move relative to the handle thereby causing the elongate pusher tomove relative to the handle; a needle having a piercing portion at adistal end of the needle, the needle movably disposed within the lumenformed by the elongate pusher, the needle forming a lumen; a needle hubcoupled to the handle and to a proximal end portion of the needle, theneedle hub configured to move relative to the handle thereby causing theneedle to move relative to the handle; a suture catch coupled to thehandle and configured to move relative to the handle; and a suturecoupled to the suture catch and extending through the lumen formed bythe needle and forming a coiled configuration at a distal end portion ofthe elongate outer tube, the suture catch being configured to releasablysecure the suture during delivery of the distal anchor, the coiledconfiguration configured to be formed into the distal anchor uponactuation of the delivery device.
 12. The delivery device of claim 11,wherein the distal anchor comprises a pre-formed knot configured to beformed and deployed by the delivery device.
 13. The delivery device ofclaim 11, wherein the needle hub, the pusher hub, and the suture catchare positioned within the handle.
 14. The delivery device of claim 11,wherein actuation of the delivery device comprises: moving distally,relative to the handle, the pusher hub, the elongate pusher, the needlehub, the needle, and the suture catch to cause the coiled configurationof the suture to extend past a distal end of the elongate tube; lockingin place the pusher hub and the elongate pusher; moving proximally,relative to the handle, the needle hub and the needle until the needlehub contacts the suture catch; moving proximally, relative to thehandle, the needle hub, the needle, and the suture catch to form thedistal anchor on a distal end of the elongate pusher; and releasing thesuture from the suture catch.
 15. The delivery device of claim 11further comprising a distal end effector coupled to a distal end portionof the elongate outer tube, the distal end effector configured todistribute a force applied by the elongate outer tube during deploymentof the distal anchor.
 16. The delivery device of claim 11, wherein theelongate outer tube comprises a stiff structure to protect the needleand the elongate pusher during delivery and deployment of the distalanchor.
 17. The delivery device of claim 11, wherein the suture catch isconfigured to secure the suture with a friction fit or a clamping force.18. The delivery device of claim 11, wherein the suture catch includes alock configured to secure the suture in place during delivery and to bereleased to release the suture after the distal anchor has beendeployed.
 19. The delivery device of claim 11, wherein the distal anchoris formed from the coiled configuration of the suture, the coiledconfiguration of the suture coils configured to change from an elongatedconfiguration during delivery to a knot configuration by approximatingopposite ends of the coiled configuration towards each other to form oneor more loops.
 20. The delivery device of claim 11, wherein the sutureincludes a length of suture between the suture catch and the proximalend of the needle that allows the suture to slide off the needle.